BL-M07D1

Phase 3Small molecule

BL-M07D1 is one of 124 small molecule programs targeting Gastroesophageal Junction Adenocarcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

123

Competitors

Pipeline

Status by Indication[3][1]

Indication

Gastroesophageal Junction AdenocarcinomaActive, not recruiting

Lung CancerActive, not recruiting

AdenocarcinomaActive, not recruiting

Breast CancerActive, not recruiting

Epithelial Ovarian CancerNot yet recruiting

Gastroesophageal Junction AdenocarcinomaPhase 2

Active, not recruiting

Lung CancerPhase 1/Phase 2

Active, not recruiting

AdenocarcinomaPhase 3

Active, not recruiting

Breast CancerPhase 3

Active, not recruiting

Epithelial Ovarian CancerPhase 3

Not yet recruiting

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

BL-M07D1

SSichuan Baili Pharmaceutical Co., Ltd.

Phase 3

7 2

Tecentriq

Roche

Preclinical

36 3

Zinecard

CChildren's Oncology Group

Preclinical

2 4

Spravato

WWim Janssens

Preclinical

2 5

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 6

Systemic Therapy

Bristol-Myers Squibb

Preclinical

1 7

Neoadjuvant Treatment

SShanghai Zhongshan Hospital

Preclinical

1 8

Perflutren Lipid Microcpheres

TThomas Jefferson University

Preclinical

2 9

Escitalopram Oxalate

TTorrent Pharmaceuticals Limited

Preclinical

1 10

QBX258

Novartis

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Gastroesophageal Junction Adenocarcinoma

NCT06423885

Q2 2027

Phase 3Recruiting

Adenocarcinoma

NCT07152405

Q4 2027

Phase 1Recruiting

Breast Cancer

NCT05461768

Phase 1Recruiting

Locally Advanced or Metastatic Digestive Tract Tumors

NCT05631964

Phase 3Recruiting

Breast Cancer

NCT06957886

Phase 1/2Recruiting

Recurrent or Metastatic

NCT06131450

Clinical

Trials by Indication[1]

Breast Cancer7 trials

A Study of BL-M07D1 With or Without Pertuzumab Versus Taxane + Trastuzumab and Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2/3·NCT06891833·120 enrolled

A Study of BL-M07D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Low Expression Breast Cancer and Other Solid Tumors

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 1·NCT05461768·26 enrolled

A Study of BL-M07D1 Versus T-DM1 in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT06830889·1,450 enrolled

Show 4 more trials

A Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-low Recurrent/Metastatic Breast Cancer

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT06957886·566 enrolled

A Study of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT06445400·120 enrolled

A Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer

Active, not recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT06316531·274 enrolled

A Randomized Controlled Phase II Clinical Study Comparing BL-M07D1 With DS-8201 in Patients With HR-Positive, HER2-Low Expressing Recurrent/Metastatic Breast Cancer

Not yet recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT07678957·120 enrolled

Gastrointestinal Tumors1 trial

A Study of BL-M07D1 in Patients With a Variety of Solid Tumors Including Locally Advanced or Metastatic HER2-positive/Low-expressing Urinary and Gastrointestinal Tumors

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 1/2·NCT06031584·42 enrolled

Adenocarcinoma1 trial

A Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-positive Locally Advanced or Metastatic Gastric or Gastro-esophageal Junction Adenocarcinoma

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT07152405·490 enrolled

Locally Advanced or Metastatic Digestive Tract Tumors1 trial

Phase I Clinical Study of BL-M07D1 in Locally Advanced or Metastatic Digestive Tract Tumors and Other Solid Tumors

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 1·NCT05631964·26 enrolled

Lung Cancer1 trial

A Study of BL-M07D1 in Patients With HER2-mutated, Locally Advanced or Metastatic Non-small-cell Lung Cancer

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 1/2·NCT06114511·98 enrolled

6 more indications

Recurrent or Metastatic1 trial

A Study of BL-M07D1 in Patients With HER2-expressing Recurrent or Metastatic Gynecologic Malignancies

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 1/2·NCT06131450·138 enrolled

Malignant Solid Tumors1 trial

Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors

Recruiting·SSystImmune Inc.·Phase 1·NCT06293898·280 enrolled

First-line Treatment1 trial

A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT07178795·440 enrolled

Non-squamous NSCLC1 trial

A Study of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous NSCLC

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT07264816·80 enrolled

Gastroesophageal Junction Adenocarcinoma1 trial

A Study of BL-M07D1 Combination Therapy in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT06423885·40 enrolled

Epithelial Ovarian Cancer1 trial

A Phase III Randomized Controlled Clinical Study Comparing BL-M07D1 With Physician's Choice of Chemotherapy in Patients With HER2-Expressing Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer

Not yet recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT07545460·404 enrolled

Sources

References

[1]
ClinicalTrials.gov — 17 trial records for BL-M07D1. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — BL-M07D1 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for BL-M07D1. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Sichuan Baili Pharmaceutical Co., Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: SSichuan Baili Pharmaceutical Co., Ltd.

BL-M07D1

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q4 2027

Trials by Indication[1]

Breast Cancer7 trials

Gastrointestinal Tumors1 trial

Adenocarcinoma1 trial

Locally Advanced or Metastatic Digestive Tract Tumors1 trial

Lung Cancer1 trial

Recurrent or Metastatic1 trial

Malignant Solid Tumors1 trial

First-line Treatment1 trial

Non-squamous NSCLC1 trial

Gastroesophageal Junction Adenocarcinoma1 trial

Epithelial Ovarian Cancer1 trial

References

Drug Info

Quick Facts

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