NCT04585035 : A Phase 1/2, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 in Subjects With Advanced or Metastatic Solid Tumors With KRasG12C Mutation

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

One/TwoPhase One/Two

18+Age Over 18

Advanced CancersCancer LocationMulti-Cancer
Trial

Systemic therapy,Treatment | Bowel (colorectum),LungColorectum,Lung,Non-Small Cell Lung Cancer

Trial Overview Read MoreRead more

This phase I/II trial will begin to understand how safe and tolerable a new cancer drug (D-1553) is as a monotherapy and combination treatment for people with advanced solid cancers that have a KRasG12C mutation.
 

This trial is treating patients with advanced solid cancers with KRasG12C mutation, including non-small cell lung cancer and colorectal (bowel) cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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

Scientific Title

A Phase 1/2, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 in Subjects With Advanced or Metastatic Solid Tumors With KRasG12C Mutation

Commercial Sponsor

InventisBio Inc.

Summary

This trial will be conducted in three parts. The first part (does escalation, Phase Ia) will evaluate up to 7 sequential cohorts with different doses of D-1553 to determine safety, tolerability, maximum tolerated dose (MTD) and recommended dose for expansion (RDE). The next part (Phase Ib) will determine the MTD of D-1553 in combination with standard treatment for patients with advanced or metastatic NSCLC, CRC and other solid tumours. The final part (Phase II) will evaluate the efficacy of D- 1553 as single agent and as a combination treatment in patients with advanced or metastatic solid tumours that have a KRas G12C mutation. Enrolment into Phase II will be opened after confirmation of the RDE.

Recruiting Hospitals Read MoreRead more

St Vincent's Hospital, Medical and Radiation Oncology
Fitzroy
Ms Nadia Ranieri
oncology.research@svha.org.au
03 9231 3167

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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