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NCT05370755 | Not yet recruiting | Patients With Advanced Solid Tumors

A Study of ICP-189 and ICP-189 in Combination With Anti-PD-1 Monoclonal Antibody in Patients With Advanced Solid Tumors
Sponsor:

Beijing InnoCare Pharma Tech Co., Ltd.

Brief Summary:

A Dose finding Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Preliminary Anti-Tumor Activity of ICP-189 Tablets and ICP-189 Tablets in Combination with Anti-PD-1 Monoclonal Antibody in Patients with Advanced Solid Tumors.

Condition or disease

Patients With Advanced Solid Tumors

Intervention/treatment

ICP-189

Phase

Phase 1

Study Type : Interventional
Estimated Enrollment : 22 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : A Phase Ia /Ib Dose Finding Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Preliminary Anti-Tumor Activity of ICP-189 and ICP-189 in Combination With Anti-PD-1 Monoclonal Antibody in Patients With Advanced Solid Tumors
Actual Study Start Date : May 31, 2022
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : January 31, 2026
Arm Intervention/treatment

Experimental: Phase Ia: ICP-189 Dose Escalation

Drug: ICP-189
Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
  • Patients with histologically confirmed locally advanced unresectable or metastatic solid tumors;
  • At least one measurable lesion according to RECIST 1.1.
Exclusion Criteria
  • Patients who have had other cancer(s) within 5 years prior to the first dose, except for locally curable cancers that have been apparently cured;
  • Patients with unstable primary central nervous system (CNS) tumors or CNS metastases;
  • Patients who have an active autoimmune disease or have had an autoimmune disease with risk of recurrence;
  • Patients who have active or history of interstitial lung disease or non-infectious pneumonia;
  • Patients who have a history of severe allergic reaction to any component of ICP-189 tablets or anti-PD-1 antibody (> grade 3 assessed by CTCAE 5.0).
  • Other protocol-defined inclusion/exclusion criteria apply.
A Study of ICP-189 and ICP-189 in Combination With Anti-PD-1 Monoclonal Antibody in Patients With Advanced Solid Tumors

Location Details

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A Study of ICP-189 and ICP-189 in Combination With Anti-PD-1 Monoclonal Antibody in Patients With Advanced Solid Tumors

How to Participate

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Locations

Not yet recruiting

China, Shanghai

Shanghai Pulmonary Hospital

Shanghai, Shanghai, China, 200433