A Phase Ia/Ib Clinical Trial of IBI360 Monotherapy or in Combination With Sintilimab and (or) Chemotherapy in Advanced or Metastatic Solid Tumors

Advanced Solid Tumor Clinical Trial

Official title:

A Phase Ia/Ib Open-Label, Multi-Center Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBI360 Monotherapy or in Combination With Sintilimab and (or) Chemotherapy in Advanced or Metastatic Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05043298
• Other study ID #: CIBI360A101
• Status: Recruiting
• Phase: Phase 1
• Start date: October 27, 2021
• Est. completion date: June 18, 2024

Study information

• Verified date: September 2022
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: feng ye
• Phone: 05922137572
• Email: yefengdoctor[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Phase Ia/Ib dose escalation and dose expansion study of IBI360 monotherapy in advanced or metastatic Solid Tumors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: June 18, 2024
• Est. primary completion date: March 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Provide signed informed consent;

2. Male or female aged at 18-75 (inclusive) years;

3. Expected survival =12 weeks;

4. ECOG PS score 0 or 1;

5. Provide archival or fresh tissues for CLDN18.2 expression analysis;

6. Adequate laboratory parameters;

7. 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:

1. The subjects who received the treatment with CLDN18.2 monoclonal antibody or CLDN-18.2 CART;

2. The subjects who received other anti-tumor medication within 4 weeks prior to the initial dose of the study drug;

3. 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;

4. The subjects with history of hypersensitivity to the study drug;

5. The subjects were not recovery after surgery with history of gastrointestinal perforation or fistula within 6 months prior to the enrollment;

6. The subjects with symptomatic central nervous system (CNS) metastasis or carcinomatous meningitis;

7. The subjects with pyloric obstruction;

8. The subjects with active or poorly controlled serious infections

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• IBI 360 Injection
IBI 360 dose level of escalation IV Q3W Day 1

Locations

Country	Name	City	State
China	Innovent Biologics (suzhou) Co. , Ltd.	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Tumor response	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
Secondary	Area under plasma concentration vs time curve(AUC)		Up to 48 weeks following first dose
Secondary	Peak plasma concentration(Cmax)		Up to 48 weeks following first dose
Secondary	Terminal Half Life(T1/2)		Up to 48 weeks following first dose
Secondary	Immunogenicity	Incidence of anti-drug antibodies (ADA) will be measured	up to 90 days following last dose