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RecruitingLast updated: 23 November 2023

INNOVENT: This study aims to evaluate how safe and tolerable a new drug (called IBI334) is in people with advanced or metastatic solid cancersA Phase 1 Study of IBI334 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

Clinical summary

Summary

This study is assessing how safe and tolerable a new drug (called IBI334) is, and also aims to determine the maximum tolerated dose (MTD) and recommended Phase 2 Dose (RP2D) of the drug is.

Eligible participants will be assigned to one of six treatment arms. In each arm, participants will receive the study drug IBI334 once a week during the first 28-day cycle (QW, 4 weeks), then biweekly (or other dose intervals as recommended by the researchers).

Conditions

This trial is treating patients with advanced or metastatic solid cancers

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

Trial Acronym

INNOVENT

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Scientific Title

A Phase 1 Study of IBI334 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

Eligibility

Inclusion

  1. Male or female subjects ≥ 18 years old;
  2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
  3. Anticipated life expectancy of ≥ 12 weeks;
  4. Adequate bone marrow and organ function;

    Criteria for dose escalation phase only:

  5. Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available (mainly focused on non-small-cell lung cancer, head and neck squamous cell carcinoma and RAS-wildtype colorectal cancer);
  6. At least 1 evaluable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;

    Criteria for dose expansion phase only:

  7. Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic non-small-cell lung cancer, head and neck squamous cell carcinoma or RAS-wildtype colorectal cancer that is refractory to or intolerable with standard treatment, or for which no standard treatment is available;
  8. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Exclusion

  1. Participate in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of the interventional study;
  2. Received live vaccines within 4 weeks prior to first dose of the study drug or plan on receiving any live vaccine during the study;
  3. Received total pelvic radiotherapy;
  4. Pyloric obstruction and/or persistent recurrent vomiting (≥ 3 times in 24 hours);
  5. Uncontrolled diseases;
  6. History of endotracheal or gastrointestinal stent implantation;
  7. Multiple concurrent malignant tumors within 5 years (except non-melanoma skin cancer, carcinoma in situ or non-invasive tumor that were cured);
  8. Women who are pregnant, have positive results in pregnancy test or are lactating;
  9. Not eligible to participate in this study at the discretion of the investigator.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.
  • but it is not possible to perform surgery to remove it.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

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

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