Active — Not RecruitingPhase 1

A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Urological Tumors and Other Solid Tumors

China4 participantsStarted 2022-02-15

Plain-language summary

In phase Ia study, the safety and tolerability of BL-B01D1 in patients with locally advanced or metastatic urinary tumors and other solid tumors will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-B01D1. In phase Ib study, the safety and tolerability of BL-B01D1 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP2D) for phase II clinical studies will be determined. In addition, the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of BL-B01D1 in patients with locally advanced or metastatic urinary tumors and other solid tumors will be evaluated.

Who can participate

Age range18 Years – 75 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

✓. Participants must sign the informed consent form voluntarily and follow the plan requirements;
✓. No gender limit;
✓. Age: ≥18 years old and ≤75 years old (stage Ia); ≥18 years old (stage Ib);
✓. Expected survival time ≥ 3 months;
✓. Locally advanced or metastatic tumors of the urinary system and other solid tumors confirmed by histopathology and/or cytology, which are incurable or currently without standard treatment. Intolerance refers to the occurrence of grade 3-4 adverse reactions after a patient has received standard treatment, and the patient refuses to continue the original treatment;
✓. Agree to provide archived tumor tissue specimens (10 unstained sections (anti-extraction) surgical specimens (thickness 4-5μm)) or fresh tissue samples from primary or metastatic lesions within 3 years. If patients cannot provide such specimens, they can be included in the group after the judgment of the investigator if other inclusion criteria are met;
✓. Participants must have at least one measurable lesion that meets the definition of RECIST v1.1;
✓. Physical fitness score ECOG 0 or 1 point;

Exclusion criteria

What they're measuring

Phase Ia: Dose limiting toxicity (DLT)

Timeframe: Up to 21 days after the first dose

Phase Ia: Maximum tolerated dose (MTD)

Timeframe: Up to 21 days after the first dose

Phase Ib: Recommended Phase II Dose (RP2D)

Timeframe: Up to 21 days after the first dose

Trial details

NCT IDNCT05393427

SponsorSichuan Baili Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12

View on ClinicalTrials.gov More Locally Advanced or Metastatic Urinary Tumors trials

Plain-language summary

Who can participate

Age range18 Years – 75 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

✓. Participants must sign the informed consent form voluntarily and follow the plan requirements;
✓. No gender limit;
✓. Age: ≥18 years old and ≤75 years old (stage Ia); ≥18 years old (stage Ib);
✓. Expected survival time ≥ 3 months;
✓. Locally advanced or metastatic tumors of the urinary system and other solid tumors confirmed by histopathology and/or cytology, which are incurable or currently without standard treatment. Intolerance refers to the occurrence of grade 3-4 adverse reactions after a patient has received standard treatment, and the patient refuses to continue the original treatment;
✓. Agree to provide archived tumor tissue specimens (10 unstained sections (anti-extraction) surgical specimens (thickness 4-5μm)) or fresh tissue samples from primary or metastatic lesions within 3 years. If patients cannot provide such specimens, they can be included in the group after the judgment of the investigator if other inclusion criteria are met;
✓. Participants must have at least one measurable lesion that meets the definition of RECIST v1.1;
✓. Physical fitness score ECOG 0 or 1 point;