The Safety and Efficacy of TWP-101 in Patients With Advanced Solid Tumor

NCT ID: NCT04871347

Last Updated: 2021-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-30

Study Completion Date

2023-12-31

Brief Summary

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This is a multi-center, phase Ia/Ib, open clinical study to evaluate the safety and efficacy of TWP-101 in patients with advanced solid tumor. 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.

Detailed Description

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Conditions

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Advanced Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation Cohort

Three dose levels of TWP-101 will be tested by a conventional 3 + 3 study design.

Group Type EXPERIMENTAL

TWP-101

Intervention Type DRUG

IV infusion

Dose Expansion Cohort

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

Group Type EXPERIMENTAL

TWP-101

Intervention Type DRUG

IV infusion

Interventions

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TWP-101

IV infusion

Intervention Type DRUG

Other Intervention Names

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Sytalizumab Injection

Eligibility Criteria

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Inclusion Criteria

* Pathologically or cytologically confirmed advanced solid tumor that failed, couldn't tolerate or refused standard treatments;
* ECOG score 0 or 1;
* 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 within 4 weeks;
* History of serious systemic diseases;
* History of serious autoimmune diseases;
* Pregnancy or lactating women.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong TheraWisdom Biopharma Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Site Status

Countries

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China

Central Contacts

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Shengbin Ren

Role: CONTACT

8021-60167707

Facility Contacts

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Qingyuan Zhang

Role: primary

0451-86298070

Other Identifiers

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TWP-101-12

Identifier Type: -

Identifier Source: org_study_id

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