A Phase Ia/Ib Clinical Trial of IBI360 Monotherapy or in... | NCT05043298

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 27, 2021Actual

Primary Completion Date

Aug 30, 2023Actual

Completion Date

Aug 30, 2023Actual

First Submitted Date

Sep 5, 2021

First Submission Date that Met QC Criteria

Sep 5, 2021

First Posted Date

Sep 14, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2024

Last Update Posted Date

Oct 17, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is an open label Phase Ia/Ib trial to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of IBI360 monotherapy in Advanced or Metastatic Solid Tumors

Detailed Description

Phase Ia is dose escalation and dose expansion study of IBI360 monotherapy and IBI360 in combination with sintilimab in advanced or metastatic Solid Tumors; Phase Ib is an multi-cohort trial of pancreatic carcinoma, HER2 negative gastric adenocarcinoma, advanced or metastatic solid tumors to evaluate safety and preliminary efSficacy of IBI360 in combination with sintilimab and (or) chemotherapy or IBI360 monotherapy.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Label	Type	Description	Intervention Names
IBI360	Experimental		Drug: IBI 360 Injection
IBI 360 + Sintilimab	Experimental		Drug: IBI 360 Injection Sintilimab

Name	Type	Description	Arm Group Labels	Other Names
IBI 360 Injection	Drug	IBI 360 dose level of escalation IV Q3W Day 1	IBI360

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerance	Participant safety is characterized by frequency and severity of adverse events(according to NCI CTCAE 5.0)	up to 90 days following last dose
Recommended Phase 2 Dose (RP2D)	A recommended phase 2 dose will be determined based on safety data including dose limiting toxicities, preliminary efficacy data, and PK data	up to 21 days following last dose level

Secondary Outcomes

Measure	Description	Time Frame
Efficacy	Tumor response will be determined by the revised Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1).	Subjects were randomized 6 months and 1 year later
Pharmacokinetics

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Provide signed informed consent;
Male or female aged at 18-75 (inclusive) years;
Expected survival ≥12 weeks;
ECOG PS score 0 or 1;
Provide archival or fresh tissues for CLDN18.2 expression analysis;
Adequate laboratory parameters;
Suffer from advanced or metastatic malignant local solid tumors confirmed by histological diagnosis and meet the criteria of the enrolled group as follows:

Ia: The subjects for whom no standard treatment regimens are available or who is intolerable to standard treatments.

Ib: pancreatic carcinoma, HER2 negative gastric adenocarcinoma, advanced or metastatic solid tumors

Exclusion Criteria:

The subjects who received the treatment with CLDN18.2 monoclonal antibody or CLDN-18.2 CART;
The subjects who received other anti-tumor medication within 4 weeks prior to the initial dose of the study drug;
Any toxicity due to previous anti-tumor therapy that has not yet resolved to NCI CTCAE v5.0 grade 0 or 1 prior to the first dose of study treatment;
The subjects with history of hypersensitivity to the study drug;
The subjects were not recovery after surgery with history of gastrointestinal perforation or fistula within 6 months prior to the enrollment;
The subjects with symptomatic central nervous system (CNS) metastasis or carcinomatous meningitis;
The subjects with pyloric obstruction;
The subjects with active or poorly controlled serious infections

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided