Safety, Tolerability and Pharmacokinetics of TWP-101 in Patients With Advanced Melanoma and Urothelial Carcinoma

Shandong TheraWisdom Biopharma

Status and phase: Unknown; Phase 1

Conditions: Advanced Melanoma; Advanced Urothelial Carcinoma

Treatments: Drug: TWP-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT04871334

TWP-101-11

Details and patient eligibility

About

This study is a multi-center, phase Ia/Ib, open clinical study to evaluate the safety, tolerability and pharmacokinetics of TWP-101 in patients with advanced melanoma and urothelial carcinoma. This study consists of two parts (Part A and Part B). Part A was a dose escalation study, and Part B was a dose expansion study.

Enrollment: 76 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathologically or cytologically confirmed advanced melanoma or urothelial carcinoma that failed, couldn't tolerate or refused standard treatments
• ECOG score 0 or 1;
• Part B: At least 1 measurable lesion according to RECIST 1.1

Exclusion criteria

• Known hypersensitivity to any ingredient of TWP-101;
• Receiving any anti-cancer drugs;
• History of serious systemic diseases;
• History of serious autoimmune diseases;
• Pregnancy or lactating women.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Dose Escalation Cohort

Experimental group

Description:

Six dose levels of TWP-101 will be tested according to an accelerated titration method followed by a conventional 3 + 3 study design.

Treatment:

Drug: TWP-101

Dose Expansion Cohort

Experimental group

Description:

Once the effective dose has been determined, an expansion cohort will be opened to evaluate the efficacy and safety of the selected dose.

Treatment:

Drug: TWP-101