Safety, Tolerability, PK, PD, Immunogenicity and Efficacy of TWP-102 in Patients With Advanced Malignancies.

Shandong TheraWisdom Biopharma

Status and phase: Unknown; Phase 1

Conditions: Advanced Malignancies

Treatments: Drug: TWP-102 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05024305

TWP-102-11

Details and patient eligibility

About

This is a multi-center, phase I, open clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and efficacy of TWP-102 injection in patients with advanced malignancies. This study consists of two parts, including a dose escalation study and a dose expansion study. The criteria for dose escalation will be based on the Bayesian optimal interval (BOIN) design with sequentially enrolled cohorts.

Enrollment: 81 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathologically confirmed advanced malignancies that failed, or not suitable for standard treatments;
• At least 1 measurable lesion.
• ECOG score 0 or 1;
• Life expectancy of ≥ 3 months;

Exclusion criteria

• Known hypersensitivity to any ingredient of TWP-102;
• Receiving any anti-cancer drugs within 4 weeks;
• History of serious systemic diseases;
• History of serious autoimmune diseases;
• Persistent toxicity of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade > 1 severity that is related to prior anti-cancer therapy. (except alopecia)
• Pregnancy or lactating women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

81 participants in 2 patient groups

Dose Escalation Cohort

Experimental group

Description:

Four dose levels of TWP-102 injection will be tested by BOIN study design.

Treatment:

Drug: TWP-102 injection

Dose Expansion Cohort

Experimental group

Description:

Once the effective doses have been determined, two expansion cohorts will be opened to evaluate the efficacy and safety in one or two tumors.

Treatment:

Drug: TWP-102 injection