Active — Not RecruitingPhase 1

A Study of SI-B003, a PD-1/CTLA-4 Bispecific Antibody, in Patients With Advanced Solid Tumors

China60 participantsStarted 2020-11-10

Plain-language summary

In phase Ia study, the safety and tolerability of SI-B003 in patients with recurrent or metastatic solid tumors will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) or maximum administered dose (MAD) for MTD is not reached of SI-B003. In the phase Ib study, the safety and tolerability of SI-B003 in specific tumors will be further investigated by selecting multiple doses based on the results of phase Ia study or/and the fixed-dose administration method with the closest exposure level, and recommended phase II dose (RP2D) for phase II clinical studies will be determined.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. The participants could understand and sign the informed consent form, and must participate voluntarily.
✓. No gender limit.
✓. Age: ≥18 years old and ≤75 years old (phase Ia); ≥18 years old (phase Ib).
✓. Expected survival time ≥ 3 months.
✓. Histologically or cytologically confirmed recurrent or metastatic solid tumor, clinical stage IIIB/IV, with radiographic or other objective evidence of disease progression after standard therapy; Or subjects were patients with solid tumors that were refractory to treatment, patients with solid tumors that did not have standard treatment, or patients who could not tolerate or had contraindications to standard treatment.
✓. For the phase Ib study:
✓. Consent to provide archival tumor tissue or fresh tissue samples of the primary or metastatic tumor, if not available, at the discretion of the investigator (only for stage Ib );
✓. At least one measurable lesion that meets the definition of RECIST v1.1 at baseline (only for stage Ib).

Exclusion criteria

What they're measuring

Phase Ia: Dose limiting toxicity (DLT)

Timeframe: Up to 28 days after the first dose of SI-B003

Phase Ia: Maximum tolerated dose (MTD)

Timeframe: Up to 28 days after the first dose of SI-B003

Phase Ia: Maximum administered dose (MAD)

Timeframe: Up to 28 days after the first dose of SI-B003

Phase Ia: Treatment-Emergent Adverse Event (TEAE)

Timeframe: Up to approximately 24 months

Phase Ib: Recommended Phase II Dose (RP2D)

Timeframe: Up to 28 days after the first dose of SI-B003

Trial details

NCT IDNCT04606472

SponsorSichuan Baili Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12

View on ClinicalTrials.gov More Solid Tumor trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. The participants could understand and sign the informed consent form, and must participate voluntarily.
✓. No gender limit.
✓. Age: ≥18 years old and ≤75 years old (phase Ia); ≥18 years old (phase Ib).
✓. Expected survival time ≥ 3 months.
✓. Histologically or cytologically confirmed recurrent or metastatic solid tumor, clinical stage IIIB/IV, with radiographic or other objective evidence of disease progression after standard therapy; Or subjects were patients with solid tumors that were refractory to treatment, patients with solid tumors that did not have standard treatment, or patients who could not tolerate or had contraindications to standard treatment.
✓. For the phase Ib study:
✓. Consent to provide archival tumor tissue or fresh tissue samples of the primary or metastatic tumor, if not available, at the discretion of the investigator (only for stage Ib );
✓. At least one measurable lesion that meets the definition of RECIST v1.1 at baseline (only for stage Ib).

Exclusion criteria

What they're measuring

Phase Ia: Dose limiting toxicity (DLT)

Timeframe: Up to 28 days after the first dose of SI-B003

Phase Ia: Maximum tolerated dose (MTD)

Timeframe: Up to 28 days after the first dose of SI-B003

Phase Ia: Maximum administered dose (MAD)

Timeframe: Up to 28 days after the first dose of SI-B003

Phase Ia: Treatment-Emergent Adverse Event (TEAE)

Timeframe: Up to approximately 24 months

Phase Ib: Recommended Phase II Dose (RP2D)

Timeframe: Up to 28 days after the first dose of SI-B003