Triple Negative Breast Cancer Clinical Trial

DelveInsight’s “Triple Negative Breast Cancer Pipeline Insight 2025” report delivers an in-depth analysis of more than 165 companies and over 170 investigational drugs currently advancing through the TNBC pipeline. The report provides detailed drug profiles across clinical and preclinical stages, along with a comprehensive evaluation of therapies by product type, development stage, route of administration, and molecule type. It also outlines discontinued and inactive candidates within the TNBC treatment landscape.

According to DelveInsight, the TNBC therapeutics market is expected to undergo substantial growth in the coming years, driven by a rising incidence of TNBC, improvements in diagnostic practices, increasing awareness, higher global healthcare expenditure, and the anticipated introduction of new treatment options.

The prevalence of triple-negative breast cancer (TNBC) has been steadily increasing in recent years, resulting in a heightened need for effective treatment options. This growing patient pool, combined with expanding research and development efforts focused on innovative therapies, is expected to propel market growth. Several companies with late-stage candidates in the pipeline include Jiangsu HengRui Medicine, G1 Therapeutics, Infinity Pharmaceuticals, and others.

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Key Takeaways from the Triple Negative Breast Cancer Pipeline Report

• In November 2025, Akeso (9926.HK) announced that its first-in-class bispecific antibody, ivonescimab (PD-1/VEGF bispecific antibody), in combination with chemotherapy for first-line treatment of triple-negative breast cancer (TNBC) has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) from China’s National Medical Products Administration (NMPA).
• In November 2025, Kazia Therapeutics Limited (Nasdaq: KZIA), an oncology-focused drug development company, announced that a patient with stage IV triple-negative breast cancer (TNBC) treated under an FDA-authorized single-patient expanded access protocol combining paxalisib with pembrolizumab (Keytruda®) and standard chemotherapy has achieved an initial immune-complete response (iCR) per iRECIST criteria. This outcome suggests a profound radiologic response in a highly aggressive metastatic cancer subtype.
• In June 2025, Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced positive data from an investigator-initiated Phase 1b clinical trial evaluating onvansertib in combination with paclitaxel in patients with metastatic triple-negative breast cancer (mTNBC) at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 30-June 3, 2025, in Chicago, Illinois.
• In June 2025, Cellectar Biosciences, Inc. (Nasdaq: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced that the company has submitted a protocol with the U.S. Food and Drug Administration (FDA) for a Phase 1b Dose Finding study of its Auger emitting radiopharmaceutical, CLR 125, for the treatment of relapsed TNBC. CLR 125 is an iodine-125 Auger-emitting drug candidate targeting solid tumors, such as triple negative breast, lung and colorectal cancers.
• In May 2025, AstraZeneca announced a phase III study assessing the Efficacy and Safety of Capivasertib + Paclitaxel Versus Placebo + Paclitaxel as First-line Treatment for Patients with Histologically Confirmed, Locally Advanced (Inoperable) or Metastatic Triple negative Breast Cancer (TNBC).
• In May 2025, MedSIR announced a phase II clinical trial that is designed to improve the tolerance of sacituzumab govitecan in patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC), refractory to at least one, and no more than two, prior standard of care chemotherapy regimens in this setting that is not amenable to resection with curative intent.
• In May 2025, Merck Sharp & Dohme LLC conducted a study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (MK-2870) in combination with pembrolizumab compared to treatment of physician’s choice (TPC) in participants with triple-negative breast cancer (TNBC) who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery.
• DelveInsight’s Triple Negative Breast Cancer Pipeline analysis depicts a robust space with 165+ active players working to develop 170+ pipeline treatment therapies.
• The leading Triple Negative Breast Cancer Companies such as G1 Therapeutics, Inc, Gilead Sciences, Biotheus Inc., GlaxoSmithKline, Hoffmann-La Roche, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, Shanghai Escugen Biotechnology, AstraZeneca, Jiangsu Hengrui Medicine, Sichuan Baili Pharmaceutical, Novartis Pharmaceuticals, Akeso Biopharma, OBI Pharma, Shanghai Jiaolian Drug Research and Development Co., Ltd, Coherent Biopharma, Daiichi Sankyo Company/Merck, SynDevRx, Inc., Treadwell Therapeutics, Merck & Co, BeBetter Med, Tasly Biopharmaceuticals Co., Ltd., Ambrx, Eli Lilly and Company, Rhizen Pharmaceuticals, Roche, TJ Biopharma Co., Ltd., Prolynx, Merck Sharp & Dohme LLC, ES-102; Hexavalent OX40 agonist antibody, INBRX-106, Processa Pharmaceuticals, Oncolytics Biotech, OncoSec Medical Incorporated, PharmAbcine, JenKem Technology, MedSIR, Zenith Epigenetics, Astellas Pharma Inc, Intensity Therapeutics, Inc., NEC Corporation, Cardiff Oncology, Ocellaris Pharma, Inc., Nuvation Bio Inc., NeoImmuneTech, Scancell Ltd, Lantern Pharma Inc., Medicenna Therapeutics, Inc., Jiangsu Alphamab Biopharmaceuticals Co., Ltd, Salubris Biotherapeutics Inc, Pfizer/Merck, Celcuity Inc., Jacobio Pharmaceuticals Co., Ltd., Immunitas Therapeutics, Innolake Biopharm, Hummingbird Bioscience, Hutchmed/BeiGene, Adagene Inc, Genmab, ProDa BioTech, Rapa Therapeutics LLC, Amgen, Strand Therapeutics Inc., Simcha Therapeutics, UCB, Sumitomo Pharma America, Inc., Shanghai Junshi Biosciences, Abbisko Therapeutics, Cytovation AS, CytosinLab Therapeutics Co., Ltd., Cantargia AB, BioAtla, Inc., BicycleTx Limited, Transgene, Bristol-Myers Squibb, BioLite, Inc., Bolt Biotherapeutics, Inc., Avenzo Therapeutics, Inc., Apollo Therapeutics Ltd, A2 Biotherapeutics Inc., Fusion Pharmaceuticals Inc., Volastra Therapeutics, Inc., Teon Therapeutics, Inc., TransThera Sciences (Nanjing), Inc., TCR2 Therapeutics, NeoTX Therapeutics Ltd., Phoenix Molecular Designs, Pure Biologics S.A., Mersana Therapeutics, Zumutor Biologics Inc., Xencor, Inc., Janux Therapeutics, Memgen, Inc., ModernaTX, Inc., Myeloid Therapeutics, Nanobiotix, NiKang Therapeutics, Inc., Numab Therapeutics AG, NextPoint Therapeutics, Inc., Nurix Therapeutics, Inc., Imugene Limited, OncoNano Medicine, Inc., Tizona Therapeutics, Inc, Theratechnologies, Exelixis, MBrace Therapeutics, LIGACHEM BIOSCIENCES Inc., Bellicum Pharmaceuticals, Compass Therapeutics, Circle Pharma, AbbVie, Adcentrx Therapeutics, Angiex, Inc., Precigen, Inc, Novartis, Laekna Limited, Light Chain Bioscience – Novimmune SA, BeiGene, SillaJen, Inc., Genentech, Inc., Accent Therapeutics, Arcus Biosciences, Inc., A2A Pharmaceuticals Inc., Adlai Nortye Biopharma Co., Ltd., Sichuan Baili Pharmaceutical Co., Ltd., Compugen Ltd, BioEclipse Therapeutics, Innate Pharma, ImmunoGenesis, Tubulis GmbH, Hinova pharmaceuticals, Repertoire Immune Medicines, VEANA THERAPEUTICS, Pharos iBio Co., Ltd., GeneQuantum Healthcare, Trio Pharmaceuticals, Cellectis, Rakovina Therapeutics, Pan Cancer T, Pinotbio, Starlight Therapeutics, Primevax, ARCE therapeutics, HC Biopharma, Casinvent, Speer Medical Technologies, Shengjing Hospital, others.
• Promising Triple Negative Breast Cancer Pipeline Therapies such as Trilaciclib, Sacituzumab Govitecan + Pembrolizumab, PM8002, Niraparib, Ipatasertib, FDA018-ADC, ESG401, Dato-DXd, Capivasertib, Camrelizumab, BL-B01D1, Alpelisib, AK112, Adagloxad Simolenin, Olaparib, B013+Nab-Paclitaxel, CBP-1008, Patritumab deruxtecan, Evexomostat, CFI-400945 + Durvalumab, Ceralasertib + Durvalumab/Nab-Paclitaxel, Carboplatin + Everolimus, Pembrolizumab and Carboplatin + Docetaxel, BEBT-209, B1962, ARX788, Bicalutamide + Abemaciclib, 9MW2821, Tenalisib, Tiragolumab, TJ107 + Pembrolizumab, Tobemstomig + Nab-Paclitaxel, PLX038, Pembrolizumab + Lenvatinib, INBRX-106 + Pembrolizumab, Vibostolimab + pembrolizumab, PCS6422 + Capecitabine, Alisertib + Paclitaxel, Pelareorep, Tavokinogene telseplasmid, Olinvacimab, JK-1201I, MEN1611, ZEN-3694, Enfortumab vedotin, INT230-6, NECVAX-NEO1, Onvansertib, OC-001, NUV-868, NT-I7, Modi-1, LP-184, MDNA11, KN046, JK08, ladiratuzumab vedotin, Gedatolisib+Talazoparib, JAB-2485, IMT-009, ILB-2109, HMBD-001, Fruquintinib+Tislelizumab, ADG106, PRO1107, ProAgio, Zimberelimab, RAPA-201, Talimogene laherparepvec, STX-001, ST-067, UCB4594, SMP3124LP, JS108, ABSK-081, CyPep-1, CTS2190, Nadunolimab, CAB-ROR2-ADC, BT8009, BT5528, BT-001, BMS-986449, BMS-986340, BLEX 404, Bemarituzumab, BDC-3042, AVZO-021, APL-5125, A2B395, FPI-1434, VLS-1488, Rina-S, TT-702, TT-00420, TC-510, Naptumomab Estafenatox, PMD-026, PBA-0405, PBA-0111, XMT-1660, ZM008, XmAb®808, JANX008, LY4052031, LY4101174, LY4170156, MEM-288, mRNA-2752, MT-302, NBTXR3, NKT3447, NKT3964, NM32-2668, NPX267, NX-1607, CF33-hNIS-antiPDL1, ONM-501, TTX-080, TH1902, XB002, MBRC-101, CS5001, iC9-CAR.B7-H3 T Cell Therapy, HMBD-002, CTX-8371, CID-078, ABBV-400, ADRX-0706, AGX101, PRGN-3007, DKY709, LAE005, Boserolimab, NI-1801, BG-68501, BAL0891, Autogene Cevumeran, ATX-295, AB598, ABBV-927, AO-252, MK-5890, AN0025, [177Lu]Lu-NNS309, BL-M02D1, COM701, CRX100, IPH4502, IMGS-001, AZD8701, TUB-030, HP518, Tumor Associated Antigen, Dark Genome Antigen, VT101, PHI-501, PHI-101, CBP-8088, GQ1010, TROP2 TIE ADC, MUC1 CAR T-cells, KT-3000, PCT-1, PBX-001, STAR-001, PV001 DV, ARM 201, Research programme: ADC, Research programme: casein kinase 1 (CK1), KT-4000, DR-18621, SHR-1316, and others.

Stay ahead with the most recent pipeline outlook for Triple Negative Breast Cancer. Get insights into clinical trials, emerging therapies, and leading companies with DelveInsight @ Triple Negative Breast Cancer Treatment Drugs

Triple Negative Breast Cancer Emerging Drugs

• Trilaciclib – G1 Therapeutics, Inc. Trilaciclib is a short-acting, intravenously administered CDK4/6 inhibitor designed to be given prior to chemotherapy. By temporarily halting cell-cycle progression, it offers two key advantages: protection of bone marrow and the immune system from chemotherapy-induced damage, and enhanced long-term immune surveillance through increased formation of specific memory T cells. The therapy is being assessed across multiple tumor types and chemotherapy regimens to evaluate its myeloprotective effects, antitumor activity, and safety when combined with cytotoxic agents and other cancer treatments. Trilaciclib is currently in Phase III development for triple-negative breast cancer (TNBC).

• Olaparib – AstraZeneca Olaparib is an oral PARP inhibitor developed by AstraZeneca and approved for BRCA-mutated TNBC. It acts by inhibiting PARP enzymes, thereby blocking cancer cell DNA repair, which is especially effective in tumors with BRCA1/2 mutations. Results from the OlympiAD trial demonstrated a significant improvement in progression-free survival (PFS) compared with chemotherapy in metastatic TNBC. It is FDA-approved for germline BRCA-mutated, HER2-negative breast cancer and is also being studied in combination with immunotherapies and chemotherapies to expand its use in TNBC. The drug is currently in Phase II/III development for TNBC.

• Patritumab Deruxtecan – Daiichi Sankyo / Merck Patritumab deruxtecan (HER3-DXd) is an investigational HER3-targeted antibody–drug conjugate created by Daiichi Sankyo. The ADC consists of a fully human anti-HER3 monoclonal antibody linked to a topoisomerase I inhibitor payload via a tumor-selective cleavable linker. As HER3 is commonly overexpressed in TNBC and associated with poorer outcomes, this agent has shown encouraging activity in a Phase 1/2 trial involving patients with HER3-positive metastatic breast cancer. Patritumab deruxtecan is now in Phase II development for TNBC.

• NUV-868 – Nuvation Bio Inc. NUV-868 is an investigational therapy being evaluated both as a monotherapy and in combination with PARP inhibitors for advanced solid tumors, including TNBC. Nuvation Bio has opted not to proceed with a Phase II trial evaluating NUV-868 alone or with olaparib or enzalutamide in the solid tumors studied in earlier phases. The company is currently reassessing future development strategies for the program, focusing on combinations with approved agents where BD2-selective BET inhibitors may offer clinical benefit. NUV-868 is in Phase I/II development for TNBC.

• TUB-030 – Tubulis TUB-030 is an antibody–drug conjugate targeting 5T4, an oncofetal antigen expressed across multiple solid tumors. The ADC uses an IgG1 antibody directed against 5T4, linked to the topoisomerase I inhibitor exatecan through Tubulis’ proprietary P5 conjugation technology, producing a homogeneous drug-to-antibody ratio (DAR) of 8. This next-generation conjugation method offers enhanced stability and favorable biophysical characteristics. TUB-030 is currently in the preclinical development stage for TNBC.

The Triple Negative Breast Cancer Pipeline report provides insights into

• The report offers comprehensive information on the companies developing therapies for Triple Negative Breast Cancer (TNBC), including a consolidated overview of the treatments each company is working on.
• It evaluates therapeutic candidates categorized by their development stages – early, mid, and late – for TNBC treatment.
• TNBC-focused companies are engaged in creating targeted therapies, with details on both active and inactive (discontinued or dormant) projects.
• The pipeline drugs for TNBC are analyzed based on development phase, route of administration, target receptors, use as monotherapy or in combination, mechanism of action, and molecular classification.
• The report also provides an in-depth review of collaborations – both industry–industry and industry – academia – along with licensing agreements and funding activities that support future progress in the TNBC market.

Explore groundbreaking therapies and clinical trials in the Triple Negative Breast Cancer Pipeline. Access DelveInsight’s detailed report now! @ New Triple Negative Breast Cancer Drugs

Triple Negative Breast Cancer Companies

G1 Therapeutics, Inc, Gilead Sciences, Biotheus Inc., GlaxoSmithKline, Hoffmann-La Roche, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, Shanghai Escugen Biotechnology, AstraZeneca, Jiangsu Hengrui Medicine, Sichuan Baili Pharmaceutical, Novartis Pharmaceuticals, Akeso Biopharma, OBI Pharma, Shanghai Jiaolian Drug Research and Development Co., Ltd, Coherent Biopharma, Daiichi Sankyo Company/Merck, SynDevRx, Inc., Treadwell Therapeutics, Merck & Co, BeBetter Med, Tasly Biopharmaceuticals Co., Ltd., Ambrx, Eli Lilly and Company, Rhizen Pharmaceuticals, Roche, TJ Biopharma Co., Ltd., Prolynx, Merck Sharp & Dohme LLC, ES-102; Hexavalent OX40 agonist antibody, INBRX-106, Processa Pharmaceuticals, Oncolytics Biotech, OncoSec Medical Incorporated, PharmAbcine, JenKem Technology, MedSIR, Zenith Epigenetics, Astellas Pharma Inc, Intensity Therapeutics, Inc., NEC Corporation, Cardiff Oncology, Ocellaris Pharma, Inc., Nuvation Bio Inc., NeoImmuneTech, Scancell Ltd, Lantern Pharma Inc., Medicenna Therapeutics, Inc., Jiangsu Alphamab Biopharmaceuticals Co., Ltd, Salubris Biotherapeutics Inc, Pfizer/Merck, Celcuity Inc., Jacobio Pharmaceuticals Co., Ltd., Immunitas Therapeutics, Innolake Biopharm, Hummingbird Bioscience, Hutchmed/BeiGene, Adagene Inc, Genmab, ProDa BioTech, Rapa Therapeutics LLC, Amgen, Strand Therapeutics Inc., Simcha Therapeutics, UCB, Sumitomo Pharma America, Inc., Shanghai Junshi Biosciences, Abbisko Therapeutics, Cytovation AS, CytosinLab Therapeutics Co., Ltd., Cantargia AB, BioAtla, Inc., BicycleTx Limited, Transgene, Bristol-Myers Squibb, BioLite, Inc., Bolt Biotherapeutics, Inc., Avenzo Therapeutics, Inc., Apollo Therapeutics Ltd, A2 Biotherapeutics Inc., Fusion Pharmaceuticals Inc., Volastra Therapeutics, Inc., Teon Therapeutics, Inc., TransThera Sciences (Nanjing), Inc., TCR2 Therapeutics, NeoTX Therapeutics Ltd., Phoenix Molecular Designs, Pure Biologics S.A., Mersana Therapeutics, Zumutor Biologics Inc., Xencor, Inc., Janux Therapeutics, Memgen, Inc., ModernaTX, Inc., Myeloid Therapeutics, Nanobiotix, NiKang Therapeutics, Inc., Numab Therapeutics AG, NextPoint Therapeutics, Inc., Nurix Therapeutics, Inc., Imugene Limited, OncoNano Medicine, Inc., Tizona Therapeutics, Inc, Theratechnologies, Exelixis, MBrace Therapeutics, LIGACHEM BIOSCIENCES Inc., Bellicum Pharmaceuticals, Compass Therapeutics, Circle Pharma, AbbVie, Adcentrx Therapeutics, Angiex, Inc., Precigen, Inc, Novartis, Laekna Limited, Light Chain Bioscience – Novimmune SA, BeiGene, SillaJen, Inc., Genentech, Inc., Accent Therapeutics, Arcus Biosciences, Inc., A2A Pharmaceuticals Inc., Adlai Nortye Biopharma Co., Ltd., Sichuan Baili Pharmaceutical Co., Ltd., Compugen Ltd, BioEclipse Therapeutics, Innate Pharma, ImmunoGenesis, Tubulis GmbH, Hinova pharmaceuticals, Repertoire Immune Medicines, VEANA THERAPEUTICS, Pharos iBio Co., Ltd., GeneQuantum Healthcare, Trio Pharmaceuticals, Cellectis, Rakovina Therapeutics, Pan Cancer T, Pinotbio, Starlight Therapeutics, Primevax, ARCE therapeutics, HC Biopharma, Casinvent, Speer Medical Technologies, Shengjing Hospital, others.

Triple Negative Breast Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Intravenous
• Subcutaneous
• Oral
• Intramuscular

Triple Negative Breast Cancer Products have been categorized under various Molecule types such as

• Monoclonal antibody
• Small molecule
• Peptide

Unveil the future of Triple Negative Breast Cancer Treatment. Learn about new drugs, pipeline developments, and key companies with DelveInsight’s expert analysis @ Triple Negative Breast Cancer Market Drivers and Barriers

Scope of the Triple Negative Breast Cancer Pipeline Report

• Coverage- Global
• Triple Negative Breast Cancer Companies- 165+
• Triple Negative Breast Cancer Pipeline Therapies- 170+
• Triple Negative Breast Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
• Triple Negative Breast Cancer Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Get the latest on Triple Negative Breast Cancer Therapies and clinical trials. Download DelveInsight’s in-depth pipeline report today! @ Triple Negative Breast Cancer Companies, Key Products and Unmet Needs

Table of Content

1. Introduction
2. Triple Negative Breast Cancer Executive Summary
3. Triple Negative Breast Cancer: Overview
4. Triple Negative Breast Cancer Pipeline Therapeutics
5. Triple Negative Breast Cancer Therapeutic Assessment
6. Triple Negative Breast Cancer – DelveInsight’s Analytical Perspective
7. Late Stage Products (Phase III)
8. Camrelizumab: Jiangsu HengRui Medicine
9. Drug profiles in the detailed report…..
10. Mid Stage Products (Phase II)
11. AK117: Akeso Biopharma
12. Drug profiles in the detailed report…..
13. Early Stage Products (Phase I)
14. PMD-026: Phoenix Molecular Designs
15. Drug profiles in the detailed report…..
16. Inactive Products
17. Triple Negative Breast Cancer Companies
18. Triple Negative Breast Cancer Products
19. Triple Negative Breast Cancer Unmet Needs
20. Triple Negative Breast Cancer Market Drivers and Barriers
21. Triple Negative Breast Cancer Future Perspectives and Conclusion
22. Triple Negative Breast Cancer Analyst Views
23. Triple Negative Breast Cancer Key Companies
24. Appendix

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