EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)

BRAF V600E • KRAS mutation • EGFR mutation • KRAS G12C • BRAF V600 • RET fusion • MET exon 14 mutation • ALK fusion • EGFR L861Q • RET mutation • ROS1 fusion • EGFR G719X • MET mutation • EGFR S768I • KRAS G12 • NTRK fusion

izalontamab brengitecan (BL-B01D1)

Izalontamab brengitecan (Iza-bren; BL-B01D1), a first-in-class EGFR-HER3 bispecific antibody-drug conjugate, for patients with EGFR-mutated NSCLC: Pooled analysis of phase 1 and phase 2 trials. (PubMed, Ann Oncol)

In this exploratory post hoc pooled analysis, Iza-bren demonstrated promising antitumor activity and a manageable safety profile in heavily pretreated EGFR-mutated NSCLC. These findings are hypothesis-generating and are being further evaluated in ongoing randomized trials.

5 days ago

P1 data • P2 data • Retrospective data • Journal

ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)

EGFR mutation

izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)

A combined strategy of EGFR-MET bispecific antibody and HER3 ADC to overcome osimertinib resistance in NSCLC. (PubMed, Cell Oncol (Dordr))

In conclusion, we have proposed a new therapeutic strategy for NSCLC after osimertinib resistance. The combined strategy of amivantamab and patritumab deruxtecan highlight a promising therapeutic avenue, warranting future clinical trials to validate safety and efficacy.

7 days ago

Journal

ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)

EGFR mutation • MET mutation

Tagrisso (osimertinib) • patritumab deruxtecan (U3-1402) • simmitinib (SYHA1817)

13d

BL-B01D1-204-11: A Study of BL-B01D1 + Pembrolizumab ± Bevacizumab in Patients With Recurrent or Metastatic Cervical Cancer and Endometrial Cancer (clinicaltrials.gov)

P2, N=96, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | N=206 --> 96

13 days ago

Enrollment change

PD-L1 (Programmed death ligand 1)

Keytruda (pembrolizumab) • Avastin (bevacizumab) • izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)

13d

BL-B01D1-204-05: A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors (clinicaltrials.gov)

P2, N=570, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | N=332 --> 570

13 days ago

Enrollment change

izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)

21d

JSKN016 in Combination With D-0502 for Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer (clinicaltrials.gov)

P1/2, N=60, Not yet recruiting, Jiangsu Alphamab Biopharmaceuticals Co., Ltd

21 days ago

New P1/2 trial

HER-2 (Human epidermal growth factor receptor 2)

HR positive • HER-2 negative

taragarestrant (D-0502)

26d

A study protocol of a single-arm, prospective, open-label, non-controlled, phase II study of neoadjuvant BL-B01D1 combined with aumolertinib in resectable stage II-IIIB non-small cell lung cancer patients with EGFR mutation. (PubMed, Transl Lung Cancer Res)

Registered on April 23, 2025. Protocol version: version 2.0, May 06, 2025.

26 days ago

P2 data • Journal

EGFR (Epidermal growth factor receptor)

EGFR mutation

Ameile (aumolertinib) • izalontamab brengitecan (BL-B01D1)

A Phase II Clinical Study Evaluating the Combination Therapy of JS212 in Patients With Advanced Lung Cancer (clinicaltrials.gov)

P2, N=864, Not yet recruiting, Shanghai Junshi Bioscience Co., Ltd.

1 month ago

New P2 trial

Loqtorzi (toripalimab-tpzi) • AWT020

CA244-0001: A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov)

P1/2, N=416, Recruiting, Bristol-Myers Squibb | N=238 --> 416 | Trial completion date: Aug 2028 --> Feb 2031 | Trial primary completion date: Dec 2026 --> Feb 2031

1 month ago

Enrollment change • Trial completion date • Trial primary completion date

Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tagrisso (osimertinib) • pumitamig (BNT327) • izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)

ICARUS-BREAST01: Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)

P2, N=139, Recruiting, Gustave Roussy, Cancer Campus, Grand Paris | Active, not recruiting --> Recruiting | N=99 --> 139 | Trial completion date: Apr 2028 --> Apr 2030 | Trial primary completion date: Apr 2025 --> Apr 2027

1 month ago

Enrollment open • Enrollment change • Trial completion date • Trial primary completion date

HER-2 (Human epidermal growth factor receptor 2)

HR positive • HER-2 negative

patritumab deruxtecan (U3-1402)

2ms

A Study of SHR-A2009 Combined With Aumolertinib Versus Aumolertinib for First-line Treatment in EGFR-mutated, Advanced or Metastatic NSCLC (clinicaltrials.gov)

P3, N=576, Recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Not yet recruiting --> Recruiting

2 months ago

Enrollment open

Ameile (aumolertinib) • ruzaltatug rezetecan (SHR-A2009)

2ms

BL-B01D1-LUNG-101: Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors (clinicaltrials.gov)

P1, N=470, Recruiting, SystImmune Inc. | N=260 --> 470 | Trial primary completion date: Dec 2025 --> Dec 2026

2 months ago

Enrollment change • Trial primary completion date

izalontamab brengitecan (BL-B01D1)