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Monoclonal Antibodies

CGX1321 in Subjects With Advanced Solid Tumors and CGX1321 With Pembrolizumab or Encorafenib + Cetuximab in Subjects With Advanced GI Tumors (Keynote 596)

Phase 1

Waitlist Available

Research Sponsored by Curegenix Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 55 months

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial is testing a new drug called CGX1321 alone and with other drugs to treat advanced cancers. It focuses on patients with GI and colorectal tumors, including those with a specific mutation. The goal is to find the safest dose and see how well the treatment works.

Eligible Conditions

Solid Tumors
Gastrointestinal Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 55 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~55 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 55 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with adverse events and/or abnormal laboratory values that are related to treatment

Secondary study objectives

CGX1321 area under the curve

CGX1321 half-life

CGX1321 maximum or peak concentration

+2 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm 3: CGX1321 in combination with encorafenib + cetuximab, dose escalation and dose expansionExperimental Treatment3 Interventions

Arm 3: Phase 1b: Ascending doses of CGX1321, once daily, orally for 3 weeks (21 days) followed by a one-week (7 day) washout period in combination with enocrafenib administered orally once daily and cetuximab administered IV once weekly

Group II: Arm 2: CGX1321 in combination with pembrolizumab dose escalation, dose expansion and Roll-over,Experimental Treatment2 Interventions

Arm 2: Roll-over Cohort: CGX1321 at a dose identified in Phase 1b, once daily, orally, for 2 weeks (14 days) followed by a one-week (7-day) washout period in combination with pembrolizumab administered IV once every three weeks (in each 21-day cycle). Arm 2: Phase 1b: Ascending doses of CGX1321, once daily, orally, for 2 weeks (14 days) followed by a one-week (7-day) washout period in combination with pembrolizumab administered IV once every three weeks (in each 21-day cycle).

Group III: Arm 1: CGX1321 Single Agent dose escalation and dose expansionExperimental Treatment1 Intervention

Arm 1: Dose Escalation Phase: Ascending doses of CGX1321 once daily, orally, for 3 weeks (21 days) followed by a one-week (7-day) washout period in each 28-day cycle Dose Expansion Phase: CGX1321, at the MTD (identified in the Dose Escalation Phase), once daily, orally, for 3 weeks (21 days) followed by a one-week (7-day) washout period in each 28-day cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

Encorafenib

FDA approved

Cetuximab

FDA approved