Gynecological MalignanciesPhase 1/2NCT06131450

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

A Phase 1/2 study testing BL-M07D1 in people with Gynecological Malignancies, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

This study is a single-arm, open, multicenter, non-randomized phase Ib/II clinical study evaluating the efficacy and safety of BL-M07D1 for injection in patients with recurrent or metastatic gynecologic malignancies. Read more about this study

Who is it for?: Ages 18 to 75 years, women only
Conditions the study is for: Gynecological Malignancies
What is being tested?: BL-M07D1
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 158 participants
Where: 1 siteChina
Study dates: 29 Feb 2024to Dec 2027
Phase: Phase 1/2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Sign the informed consent form voluntarily and follow the protocol requirements;
Female;
Age: ≥18 years old and ≤75 years old;
Expected survival time ≥3 months;
patients with recurrent or metastatic HER2-positive/low-expression gynecologic malignancies who have failed or are intolerant to standard treatment or who currently have no standard treatment;
The histopathology of gynecological malignant tumors should meet the following conditions: HER2 positive; Low expression of HER2;

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Consent to provide archived tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 2 years;
At least one measurable lesion meeting the RECIST v1.1 definition was required;
ECOG score 0 or 1;
The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
No blood transfusion, use of any cell growth factors and/or platelet-raising drugs were allowed within 14 days before screening, and the organ function level had to be acceptable;
Urinary protein ≤2+ or ≤1000mg/24h;
albumin ≥30 g/L;
Women who are likely to give birth must have negative serum/urine pregnancy within 7 days before treatment and must be non-lactating; All enrolled patients should have adequate contraception throughout the treatment cycle and for 6 months after the end of treatment.

Who cannot join

had received anti-tumor therapy before the first dose; Mitomycin and nitrosoureas; Oral fluorouracils; Palliative radiotherapy; Anti-tumor traditional Chinese medicine or Chinese patent medicine;
had received prior ADC drug therapy with camptothecin derivative (topoisomerase I inhibitor) as toxin;
had a history of serious cardiovascular and cerebrovascular diseases;
active autoimmune or inflammatory diseases;
Patients with other malignant tumors within 5 years before the first administration, except cured skin squamous cell carcinoma, basal cell carcinoma, superficial bladder cancer and prostate/cervix/breast cancer in situ;
Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring medical intervention within 6 months before screening;

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patients with massive or symptomatic effusions or poorly controlled effusions;
Hypertension poorly controlled by antihypertensive drugs (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg);
Current interstitial lung disease, drug-induced interstitial pneumonia, radiation pneumonitis requiring steroid therapy, or a history of these diseases;
patients with central nervous system (CNS) metastases and/or carcinomatous meningitis (meningeal metastases);
patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any ingredient of BL-M07D1;
patients received previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
HIVAb positive, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
active infections requiring systemic therapy, such as severe pneumonia, bacteremia, sepsis, etc.;
had participated in another clinical trial within 4 weeks before the first dose;
pregnant or lactating women;
The investigator did not consider it appropriate to apply other criteria for participation in the trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sa Xiao, PHD contact

+8615013238943

xiaosa@baili-pharm.com

China1 site, 1 recruiting

Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Lingying Wu
Recruiting

Other trials in China

About this study

Official title: A Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 for Injection in Patients With Recurrent or Metastatic Gynecologic Malignancies

Conditions: Gynecological Malignancies
Being tested: BL-M07D1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BL-M07D1Drug
Administration by intravenous infusion

Study groups in NCT06131450
Study group	Role	What they receive
BL-M07D1	Experimental	Participants receive BL-M07D1 as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons. Receives: Drug: BL-M07D1

What is being measured

The primary outcome is the main question the study is designed to answer.

Phase Ib: Recommended Phase II Dose (RP2D)
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-M07D1.
Measured: Up to approximately 24 months
Phase II: Objective Response Rate (ORR)
ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.
Measured: Up to approximately 24 months

Secondary outcomes (9)

Treatment-Emergent Adverse Event (TEAE)
TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-M07D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M07D1.
Measured: Up to approximately 24 months
Phase Ib: Objective Response Rate (ORR)
ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.
Measured: Up to approximately 24 months
Disease Control Rate (DCR)
The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]).
Measured: Up to approximately 24 months
Duration of Response (DOR)
The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.
Measured: Up to approximately 24 months
Progression-free Survival (PFS)
The PFS is defined as the time from the participant's first dose of BL-M07D1 to the first date of either disease progression or death, whichever occurs first.
Measured: Up to approximately 24 months
Cmax
Maximum serum concentration (Cmax) of BL-M07D1 will be investigated.
Measured: Up to approximately 24 months
Tmax
Time to maximum serum concentration (Tmax) of BL-M07D1 will be investigated.
Measured: Up to approximately 24 months
Ctrough
Ctrough is defined as the lowest serum concentration of BL-M07D1 prior to the next dose will be administered.
Measured: Up to approximately 24 months
ADA (anti-drug antibody)
Frequency of anti-BL-M07D1 antibody (ADA) will be investigated.
Measured: Up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Feb 2024Dec 2027

First posted14 Nov 2023
Study start29 Feb 2024
Primary completionJan 2027 (estimated)
Study completionDec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Gynecological MalignanciesStudies of the same condition, open and under way.
More trials run by Sichuan Baili Pharmaceutical Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 158 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06131450
Sponsor's protocol ID: BL-M07D1-203
Status last verified: Oct 2026
First submitted: 9 Nov 2023
Last updated: 23 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Sa Xiao, PHD

+8615013238943

xiaosa@baili-pharm.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Gynecological Malignancies trials