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A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-21822 Monotherapy and Combination Therapy in Adult Patients with Advanced Solid Tumors Harboring KRAS G12C Mutation
EU CTIS ID: 2024-515258-25-00
What this study is testing
Dose Escalation Phase (Phase 1): 1. To evaluate the overall safety and tolerability of JAB-21822 monotherapy 2. To determine the MTD and a RP2D of JAB-21822 monotherapy administered QD in participants with relapsed or refractory solid tumors with KRAS G12C mutation Dose Expansion Phase (Phase 2): 1. To further evaluate preliminary antitumor activity, ORR, and DOR of JAB-21822 monotherapy at the RP2D in participants with relapsed and refractory NSCLC and other solid tumors with KRAS G12C mutation, and in combination with cetuximab in mCRC with KRAS G12C mutation
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants must have at least 1 measurable lesion as defined by RECIST v1.1.
- Participants must be able to provide an archived tumor sample
- Participant has histologically or cytologically confirmed solid tumors with KRAS G12C mutation
- Must have received at least 1 prior standard therapy
- Participants must be able to swallow and retain orally administered medication.
- Participants must have laboratory data that meet the following criteria: a. Absolute neutrophil count ≥1.5 × 109/L. b. Platelet count ≥100 × 109/L. c. Hemoglobin ≥9 g/dL. d. Albumin ≥3.0 g/dL. e. Total bilirubin ≤1.5 × ULN (with Gilbert’s syndrome, ≤2.0 × ULN). f. AST and ALT ≤1.5 × ULN (with presence of liver metastases, ≤3 × ULN). g. PT and PTT <1.5 × ULN and INR <1.5 if the participant is not on anticoagulants, or INR <3 after dose titration has been completed if the participant is on anticoagulants. h. Kidney function is normal with a CrCl ≥ 60 mL/min (measured using Cockcroft-Gault equation; see Appendix 13.4). i. TSH within normal range at baseline. Additional thyroid function testing (such as free T4, T3, etc.) can be performed at the investigator’s discretion.
You likely can't join if
- Active infection requiring systemic treatment at the start of treatment in this trial. A washout period of 7 days after the last dose of antibiotics, antivirals, or antifungals prior to first dose of study drug is required.
- Participant has brain or spinal metastases, except if treated by surgery, surgery plus radiotherapy or radiotherapy alone, with no evidence of radiographic progression or hemorrhage for at least 28 days
- Has active HBV or HCV
- History of any severe and/or uncontrolled medical conditions
- LVEF ≤50% assessed by ECHO or QTcF
- QT interval >470 msec
See the full eligibility criteria
- Participants must have at least 1 measurable lesion as defined by RECIST v1.1.
- Participants must be able to provide an archived tumor sample
- Participant has histologically or cytologically confirmed solid tumors with KRAS G12C mutation
- Must have received at least 1 prior standard therapy
- Participants must be able to swallow and retain orally administered medication.
- Participants must have laboratory data that meet the following criteria: a. Absolute neutrophil count ≥1.5 × 109/L. b. Platelet count ≥100 × 109/L. c. Hemoglobin ≥9 g/dL. d. Albumin ≥3.0 g/dL. e. Total bilirubin ≤1.5 × ULN (with Gilbert’s syndrome, ≤2.0 × ULN). f. AST and ALT ≤1.5 × ULN (with presence of liver metastases, ≤3 × ULN). g. PT and PTT <1.5 × ULN and INR <1.5 if the participant is not on anticoagulants, or INR <3 after dose titration has been completed if the participant is on anticoagulants. h. Kidney function is normal with a CrCl ≥ 60 mL/min (measured using Cockcroft-Gault equation; see Appendix 13.4). i. TSH within normal range at baseline. Additional thyroid function testing (such as free T4, T3, etc.) can be performed at the investigator’s discretion.
- Active infection requiring systemic treatment at the start of treatment in this trial. A washout period of 7 days after the last dose of antibiotics, antivirals, or antifungals prior to first dose of study drug is required.
- Participant has brain or spinal metastases, except if treated by surgery, surgery plus radiotherapy or radiotherapy alone, with no evidence of radiographic progression or hemorrhage for at least 28 days
- Has active HBV or HCV
- History of any severe and/or uncontrolled medical conditions
- LVEF ≤50% assessed by ECHO or QTcF
- QT interval >470 msec
- Participants experiencing unresolved Grade >1 toxicity before the start of treatment with the study drug
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.