This is Phase Ib/II, multicenter, open-label adaptive platform study of JDQ443 with select
      therapies in patients with advanced solid tumors harboring the KRAS G12C mutation.

Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

KRAS G12C Mutant Solid Tumors

Carcinoma, Non-Small Cell Lung

Carcinoma, Non-Small-Cell Lung

Non-Small Cell Lung Cancer

Non-Small Cell Lung Carcinoma

Nonsmall Cell Lung Cancer

Colorectal Cancer

Colorectal Carcinoma

Colorectal Neoplasms

Colorectal Tumors

Neoplasms, Colorectal

JDQ443 will be considered "backbone" treatment in this trial and combined with selected
      therapies, or "partner(s)". The combination of a backbone and a partner will constitute a
      treatment arm. After dose escalation, treatment arms that reach a maximum tolerated dose
      /recommended dose and are determined to be safe may, but are not required to, proceed to
      Phase II to further explore safety, tolerability, and anti-tumor activity.

JDQ443

trametinib

Ribociclib

cetuximab

KontRASt-03: A Phase Ib/II, Multicenter, Open-label Platform Study of JDQ443 With Select Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value that is not primarily related to disease, disease progression, intercurrent illness/injury, or concomitant medications that occurs within the first 28 days of study treatment and meets a defined criteria.

All information obtained on AE will be displayed by treatment group. Summary tables will include only AEs that started/worsened during the cycles of treatment (treatment-emergent AEs).

The number of patients with dose adjustments (reductions and interruptions) will be summarized by treatment group.

Dose intensity is defined as the ratio of actual cumulative dose received and actual duration of response.

ORR is the proportion of patients with a best overall response (BOR) of Complete Response (CR) or Partial Response (PR).

ORR is the proportion of patients with a BOR of CR or PR.

DCR is the proportion of patients with a BOR of CR or PR or Stable Disease (SD). The objective of this endpoint is to summarize patients with signs of "activity" defined as either shrinkage of tumor (regardless of duration) or slowing down of tumor growth.

Duration of response is defined as the time from the date of the first documented response (CR or PR), to the date of first documented progression, or death due any cause.

PFS is defined as the time from the date of start of treatment to the date of the first documented progression, or death due to any cause. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment.

DCR is the proportion of patients with a BOR of CR or PR or SD. The objective of this endpoint is to summarize patients with signs of "activity" defined as either shrinkage of tumor (regardless of duration) or slowing down of tumor growth.

OS is defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient is not known to have died, survival will be censored at the date of last known date patient alive.

The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass x volume-1)

Observed concentration at the end of a dosing interval (taken directly before next administration)

The time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration (time)

The Area under curve calculated to the end of a dosing interval (tau) at steady-state (amount x time x volume-1)

Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status