RecruitingPhase 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 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


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

130 participants

Start Date

Nov 6, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests two investigational therapies — BL-B01D1 (an antibody-drug conjugate) and SI-B003 (an immunotherapy) — alone and in combination, in women with recurrent or metastatic cervical cancer and other gynecological cancers that have not responded to standard treatment. **You may be eligible if...** - You are a woman between 18 and 75 years old - You have a confirmed diagnosis of recurrent or metastatic cervical cancer or another gynecological malignancy - Your cancer has failed or you cannot tolerate standard treatments - Your expected survival is at least 3 months and you have good physical function (ECOG 0-1) **You may NOT be eligible if...** - You are outside the 18-75 age range - Your gynecological cancer has not been confirmed by pathology - Your overall health is too poor to tolerate investigational treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBL-B01D1

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

DRUGSI-B003

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


Locations(1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

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NCT05990803


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