2023-01-16T00:00:00.000+08:00
Ongoing

RC48-G001

RC48-G001
Urothelial cancer

A Phase 2 Multi Cohort, Open Label, Multi-Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48-ADC) Alone and in Combination with Pembrolizumab in Subjects with Locally Advanced Unresectable or Metastatic Urothelial Carcinoma That Expresses HER2

A Phase 2 Multi Cohort, Open Label, Multi-Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48-ADC) Alone and in Combination with Pembrolizumab in Subjects with Locally Advanced Unresectable or Metastatic Urothelial Carcinoma That Expresses HER2

Trial overview

Topic

Urothelial cancer

Study details

This study is being done to see if a drug called disitamab vedotin, alone or with pembrolizumab, works to treat HER2 expressing urothelial cancer. It will also test how safe the drug is for participants.

Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).

It will also study what side effects happen when participants get the drug. A side effect is anything a drug does to your body besides treating the disease.

Eligibility criteria

Inclusion Criteria:

  • Histologically-confirmed, locally-advanced, unresectable or metastatic urothelial cancer (LA/mUC), including UC originating from the renal pelvis, ureters, bladder, or urethra
  • Cohorts A and B: Participants must have received only 1 or 2 lines of prior systemic treatment for LA/mUC, including 1 line of platinum-containing chemotherapy
  • Cohort C: No prior systemic therapy for LA/mUC
  • Cohorts A and B only: Radiographically documented disease progression during or after the most recent line of therapy for LA/mUC
  • Cohort C only: Participant is eligible to receive cisplatin- or carboplatin- containing chemotherapy per investigator evaluation
  • HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample

Exclusion Criteria:

  • Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study
  • Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)
  • Prior MMAE-based ADCs (eg, enfortumab vedotin) or HER2-directed therapy
  • Peripheral sensory or motor neuropathy ≥ Grade 2 at baseline

There are additional inclusion and exclusion criteria. The study centre will determine if criteria for participation are met.

Further information

Please click here for more information

Location
North Shore :::

Thank you for submitting.

We will be in touch within 24 hours

An unexpected error has occurred.

You will need to complete the form again, sorry for the inconvenience.

How can we help?

If you have a medical emergency please call 000. If you have an urgent request and would like to speak to our staff, please contact one of our centres directly.

* Indicates a required field.