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Cervical CancerPhase 2NCT05990803

A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies

A Phase 2 study testing BL-B01D1 and SI-B003 in people with Cervical Cancer, 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

Objective: To explore the efficacy, safety and tolerability of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in patients with recurrent or metastatic cervical cancer and other gynecological malignancies, and to further explore the optimal dose and mode of combination. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Cervical Cancer
What is being tested?
BL-B01D1 and SI-B003
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 siteChina
Study dates
6 Nov 2023to Dec 2027
Phase
Phase 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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject volunteered to participate in the study and signed an informed consent;
  • Women aged ≥18 years and ≤75 years;
  • Expected survival time ≥3 months;
  • ECOG score 0-1;
  • Gynecological malignancies such as recurrent or metastatic cervical cancer confirmed by histopathology and/or cytology after failure or intolerance to standard treatment or for which no standard treatment is available;
  • Agree to provide 10 surgical specimens or fresh tissue samples of primary or metastatic tumors within 3 years;
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  • At least one measurable lesion meeting the RECIST v1.1 definition was required;
  • No blood transfusion, colony-stimulating factor, any cell growth factor injection, or albumin injection were allowed within 14 days before the first use of the study drug, and the organ function level must meet the requirements;
  • Urine protein ≤2+ or ≤1000g/24h;
  • No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
  • The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
  • For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, a serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.

Who cannot join

  • Prior treatment with an ADC drug with a topoisomerase I inhibitor as a toxin;
  • Use of antineoplastic therapy within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral fluorouracil or palliative radiotherapy within 2 weeks before the first dose;
  • Cohort_B and Cohort_C with a history of immunotherapy and grade ≥3 irAE or grade ≥2 immune-related myocarditis;
  • Cohort_B, Cohort_C, who had received an immunomodulatory drug within 14 days before the first dose of study drug;
  • Had a history of serious cardiovascular and cerebrovascular diseases;
  • Active autoimmune and inflammatory diseases;
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  • Other malignant tumors that progressed or required treatment within 5 years before the first dose;
  • A history of ILD requiring steroid therapy, current ILD, or suspected ILD at screening that could not be ruled out by imaging;
  • History of poorly controlled diabetes mellitus, poorly controlled hypertension, or hypertensive crisis or hypertensive encephalopathy before the first medication;
  • New onset of deep vein thrombosis within 14 days before screening or pulmonary embolism within 6 months;
  • Patients with active central nervous system metastases;
  • Patients with massive, symptomatic, poorly controlled, or unstable effusions;
  • Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any of BL-B01D1's excipients;
  • Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
  • Human immunodeficiency virus antibody 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;
  • Who have a history of psychotropic drug abuse and cannot quit or have mental disorders;
  • Patients with a history of intestinal obstruction within 6 months before the screening period;
  • Other circumstances that the investigator deemed inappropriate 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 II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 Monotherapy, SI-B003 Monotherapy and BL-B01D1+SI-B003 Combination Therapy (BL-B01D1+SI-B003) in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies

Objective: To explore the efficacy, safety and tolerability of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in patients with recurrent or metastatic cervical cancer and other gynecological malignancies, and to further explore the optimal dose and mode of combination.

Read the detailed description

Objective: To explore the efficacy of BL-B01D1 monotherapy, SI-B003 monotherapy, and BL-B01D1+SI-B003 combination therapy in patients with recurrent or metastatic cervical cancer. To explore the safety and tolerability of BL-B01D1 monotherapy, SI-B003 monotherapy and BL-B01D1+SI-B003 combination therapy in patients with recurrent or metastatic cervical cancer and other gynecological malignancies, and to further explore the optimal dose and mode of combination therapy.

Conditions
Cervical Cancer
Being tested
BL-B01D1, SI-B003
Keywords
Gynecological malignancies
Medical subject headings
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

    BL-B01D1 was administered by intravenous infusion on D1 and D8 in a 3-week cycle.

  • SI-B003Drug

    SI-B003 was administered by intravenous infusion every 3 weeks (Q3W).

Study groups in NCT05990803
Study groupRoleWhat they receive
Study treatmentExperimentalParticipants received BL-B01D1, SI-B003 or BL-B01D1 + SI-B003 therapy in the first cycle (3 weeks). Participants who had a clinical benefit could receive additional cycles of additional treatment. Administration will be discontinued because of disease progression or intolerable toxicity or for other reasons.
Receives: Drug: BL-B01D1; Drug: SI-B003

What is being measured

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

  1. 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

  2. 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 .

    Measured: Up to approximately 24 months

Secondary outcomes (4)

  1. Progression-free survival (PFS)

    The PFS is defined as the time from the first dose of medication to disease progression or death, whichever occurred first.

    Measured: Up to approximately 24 months

  2. 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

  3. 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

  4. Treatment-Emergent Adverse Event (TEAE)

    TEAE is defined as any adverse and unexpected change in body structure, function, or chemistry or any exacerbation of an existing condition (i.e., any clinically significant adverse change in frequency and/or intensity) during treatment. The type, frequency, and severity of TEAE will be assessed during treatment.

    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 posted14 Aug 2023
  2. Study start6 Nov 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05990803
Sponsor's protocol ID
BL-B01D1-SI-B003-201-08
Status last verified
Sep 2025
First submitted
7 Aug 2023
Last updated
26 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BL-B01D1 and SI-B003 in people with Cervical Cancer, 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 12 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 phase mean?

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?

Objective response rate (ORR) (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 NCT05990803.

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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