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Closed (no longer recruiting)Last updated: 28 February 2024

ICP-CL-00303: This Phase I/II trial is evaluating how safe and tolerable a new targeted therapy (ICP-192) is in people with advanced solid cancers, gall bladder cancer or bladder cancerA Multi-center Open-label, Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ICP-192 in Patients With Advanced Solid Tumors and FGFR Gene Alterations

Clinical summary

Summary

This is an open-label trial to evaluate ICP-192 in patients with advanced solid tumours and FGFR gene alterations. It consists of two parts: Part I dose escalation, and Part II dose expansion. Part I will consist of patients with advanced solid tumours, and they will be treated with ICP-192 following the "3+3" dose escalation scheme. Part II will consist of patients with urothelial carcinoma or cholangiocarcinoma with FGFR gene alterations, and they will be treated with a singe dose of ICP-192 as defined from Part I.

Conditions

This trial is treating patients with advanced solid cancer, bladder cancer and gall bladder cancer.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I/II

Trial Acronym

ICP-CL-00303

More information

Trial Identifiers

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Trial sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Scientific Title

A Multi-center Open-label, Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ICP-192 in Patients With Advanced Solid Tumors and FGFR Gene Alterations

Eligibility

Inclusion

Participants are eligible to be included in the study only if all of the following criteria apply:

  1. Participate voluntarily, sign informed consent, and follow the study treatment plan and scheduled visits;
  2. Phase I: Patients with histologically or cytologically confirmed unresectable or metastatic advanced malignant solid tumors who have progressed under standard treatment or recurred after or were intolerant to all standard treatment regimens, or have no standard treatment available;
  3. Phase II: patients with histologically or cytologically confirmed unresectable or metastatic urothelial carcinoma or cholangiocarcinoma, who have progressed or recurred after or were intolerant to first-line chemotherapy, or have progressed/relapsed within 12 months after neoadjuvant /adjuvant chemotherapy;
  4. Phase II: Existing test reports have confirmed the FGFR gene alteration or the central laboratory has detected the FGFR gene alteration.
  5. Age ≥18 years old;
  6. At least one measurable lesion according to the Response Evaluation Criteria of Solid Tumor, version 1.1 (RECIST 1.1);
  7. ECOG performance status of 0-1;
  8. Life expectancy for more than 3 months; Must have adequate organ function Major Exclusion Criteria

Exclusion

Participants are excluded from the study if any of the following criteria apply:

  1. Have previously been treated with selective pan-FGFR molecular inhibitors or antibody drugs, except for the FGFR4 selective inhibitors;
  2. Within 2 weeks before the first dose of study drug, the subject's phosphate level continuing to exceed the ULN despite medical treatment;
  3. Patients with clinically significant gastrointestinal dysfunction
  4. Has known central nervous system metastases;
  5. Has a history of or currently uncontrolled cardiovascular diseases
  6. History of organ transplantation or a history of allogeneic hematopoietic stem cell transplantation;
  7. Current evidence of corneal or retinal abnormalities that may increase eye toxicity;
  8. Active hepatitis B virus active hepatitis C, or HIV infection;
  9. Has not recovered from reversible toxicity of prior anti-tumor therapy
  10. Pregnant or lactating women, as well as women with childbearing potential who are unwilling or unable to perform contraception from the screening to 6 months after the last study drug administration; and fertile men who are unwilling or unable to perform contraception from screening to 3months after the last study drug administration
  11. Other conditions considered by the investigator to be inappropriate for participation in this study.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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