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Gynecological Malignant TumorPhase 1/2NCT05803018

A Study of BL-B01D1 in Patients With Multiple Solid Tumors, Including Recurrent or Metastatic Gynecological Malignancies

A Phase 1/2 study testing BL-B01D1 in people with Gynecological Malignant Tumor and Solid Tumor, 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

A phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy of BL-B01D1 for injection in patients with multiple solid tumors, including recurrent or metastatic gynecological malignancies. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gynecological Malignant Tumor, Solid Tumor
What is being tested?
BL-B01D1
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteChina
Study dates
25 Jun 2023to Dec 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily sign the informed consent form and comply with the protocol requirements;
  • Age: ≥18 years and ≤75 years;
  • Expected survival time ≥3 months;
  • Histologically and/or cytologically confirmed recurrent or metastatic gynecological malignancies with failed standard treatment, intolerance to standard treatment, or no current standard treatment available;
  • Agree to provide archived tumor tissue specimens (10 slides) or fresh tissue samples from primary or metastatic lesions within the past 3 years;
  • Must have at least one measurable lesion as defined by RECIST v1.1;
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  • ECOG performance status score of 0 or 1;
  • Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
  • No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;
  • Organ function levels must meet the requirements without transfusion, albumin, colony-stimulating factors, any cell growth factors, and/or platelet-raising drugs within 14 days before the first dose of the study drug;
  • Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × ULN;
  • Urine protein ≤2+ or ≤1000 mg/24h;
  • For premenopausal women with childbearing potential, a pregnancy test (serum or urine) must be performed within 7 days before starting treatment, and the result must be negative; they must not be breastfeeding. All enrolled patients must use adequate barrier contraception throughout the treatment period and for 6 months after treatment ends.

Who cannot join

  • Received chemotherapy, biological therapy, immunotherapy, or other antitumor treatments within 4 weeks or 5 half-lives prior to the first dose (6 weeks for mitomycin and nitrosoureas; oral fluorouracil drugs, etc.);
  • History of severe heart disease;
  • Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, or severe arrhythmia;
  • Active autoimmune or inflammatory diseases;
  • Other malignancies with progression or requiring treatment within 5 years prior to the first dose;
  • Poorly controlled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg) despite the use of two antihypertensive medications;
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  • Poorly controlled blood glucose levels;
  • History of interstitial lung disease (ILD), current ILD, or suspected ILD based on imaging during screening;
  • Concurrent pulmonary disease leading to clinically significant respiratory impairment;
  • Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
  • Patients with central nervous system (CNS) metastases and/or carcinomatous meningitis (leptomeningeal metastases);
  • Patients with significant serous cavity effusion, symptomatic effusion, or poorly controlled effusion;
  • History of hypersensitivity to recombinant humanized antibodies or human-mouse chimeric antibodies, or any excipients of BL-B01D1;
  • Imaging findings indicating tumor invasion or encasement of major thoracic, cervical, or pharyngeal blood vessels;
  • Previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
  • Cumulative anthracycline dose >360 mg/m² in prior (neo)adjuvant anthracycline therapy;
  • Positive for human immunodeficiency virus (HIV) antibodies, active tuberculosis, active hepatitis B virus (HBV) infection, or active hepatitis C virus (HCV) infection;
  • Severe infection within 4 weeks before the first dose of the study drug; signs of active pulmonary infection within 2 weeks before the first dose;
  • Participation in another clinical trial within 4 weeks before the first dose;
  • Any other condition deemed unsuitable for participation in this clinical trial by the investigator.

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

  • Fudan University ShangHai Cancer Center

    Shanghai, Shanghai Municipality

    Weijing Zhang, 021-64175590-88503, JJYIN555@163.com

    Xiaohua Wu

    Recruiting

Other trials in China

About this study

Official title: A Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-B01D1 for Injection in Patients With Multiple Solid Tumors, Including Recurrent or Metastatic Gynecological Malignancies

A phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy of BL-B01D1 for injection in patients with multiple solid tumors, including recurrent or metastatic gynecological malignancies.

Read the detailed description

Phase Ib: To explore the safety and initial efficacy of BL-B01D1 in a variety of solid tumors, including recurrent or metastatic gynecological malignancies, to further identify RP2D. To evaluate the initial efficacy of BL-B01D1. The pharmacokinetic characteristics and immunogenicity of BL-B01D1 were further evaluated. Phase II: To explore the efficacy of BL-B01D1 as a single agent RP2D in patients with multiple solid tumors such as recurrent or metastatic gynecological malignancies using Phase Ib clinical studies. To evaluate the safety and tolerance of BL-B01D1. To evaluate the pharmacokinetic characteristics and immunogenicity of BL-B01D1.

Being tested
BL-B01D1
Keywords
Ovarian Cancer, Endometrial Carcinoma, Cervical Cancer, Tubal carcinoma
Medical subject headings
Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms

What participants receive

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

  • BL-B01D1Drug

    Also called iza-bren, izalontamab brengitecan, BMS-986507

    Administration by intravenous infusion

Study groups in NCT05803018
Study groupRoleWhat they receive
Study treatmentExperimentalParticipants receive BL-B01D1 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-B01D1

What is being measured

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

  1. 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-B01D1.

    Measured: Up to approximately 24 months

  2. 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 (12)

  1. Phase Ib/II: 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-B01D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1.

    Measured: Up to approximately 24 months

  2. 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

  3. Phase II: Progression-free survival (PFS)

    The PFS is defined as the time from the participant's first dose of BL-B01D1 to the first date of either disease progression or death, whichever occurs first.

    Measured: Up to approximately 24 months

  4. Phase Ib/II: 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

  5. Phase Ib/II: 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

  6. Phase Ib/II: Cmax

    Maximum serum concentration (Cmax) of BL-B01D1 will be investigated.

    Measured: Up to approximately 24 months

  7. Phase Ib/II: Tmax

    Time to maximum serum concentration (Tmax) of BL-B01D1 will be investigated.

    Measured: Up to approximately 24 months

  8. Phase Ib: T1/2

    Half-life (T1/2) of BL-B01D1 will be investigated.

    Measured: Up to approximately 24 months

  9. Phase Ib: AUC0-t

    Blood concentration - Area under time line.

    Measured: Up to approximately 24 months

  10. Phase Ib: CL

    To study the serum clearance rate of BL-B01D1 per unit time.

    Measured: Up to approximately 24 months

  11. Phase Ib/II: Ctrough

    Ctrough is defined as the lowest serum concentration of BL-B01D1 prior to the next dose will be administered.

    Measured: Up to approximately 24 months

  12. Phase Ib/II: Anti-drug antibody (ADA)

    Frequency and titer of anti-BL-B01D1 antibody (ADA) will be evaluated.

    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.

  1. First posted7 Apr 2023
  2. Study start25 Jun 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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
Sequential
Masking
None (open label)
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05803018
Sponsor's protocol ID
BL-B01D1-202
Status last verified
Sep 2025
First submitted
23 Mar 2023
Last updated
26 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BL-B01D1 in people with Gynecological Malignant Tumor and Solid Tumor, run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sa Xiao, PHD (+8615013238943, xiaosa@baili-pharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase Ib: Recommended Phase II Dose (RP2D) (time frame: Up to approximately 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05803018.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.

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