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Also known as JAB-21822
JAB 21822 · 1 trial · 1 indication
A DLT is defined as the clinically significant treatment-related adverse event or abnormal laboratory values assessment during the first 21 days of Cycle 1. It excludes adverse events (AEs) that are deemed clearly related to underlying disease, progression, or intercurrent illness.
Patients will be assessed for incidence and severity of AEs according to NCI-CTCAE 5.0 criteria
ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1
| Arm | Type | Description |
|---|---|---|
| Phase 1 ,Dose Exploration ,monotherapy | EXPERIMENTAL | Dose escalation of JAB21822 will be administered as monotherapy to determine the MTD and RP2D |
| Phase 2, Dose Expansion, Part1 monotherapy | EXPERIMENTAL | Part 1 dose expansion is to evaluate the safety and clinical activity of JAB-21822 at RP2D in subjects with previously untreated advanced non-small cell lung cancer (NSCLC) |
| Phase 2 Dose Expansion, Part 2 monotherapy | EXPERIMENTAL | Part 2 dose expansion is to evaluate the safety and clinical activity of JAB-21822 at RP2D in subjects who had received at least one previous line of systemic therapy for NSCLC |
| Name | Type | Description |
|---|---|---|
| JAB 21822 | DRUG | Administered orally |
Inclusion Criteria: 1. Pathologically documented, locally-advanced or metastatic NSCLC with KRAS p.G12C mutation identified through molecular testing. 2. STK11 co-mutation and KEAP1 Wild-Type (local confirmation) 3. Treatment naïve or have received at least 1 prior standard therapy for advanced NSC...
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JAB 21822 is an investigational small molecule being studied for the treatment of advanced solid tumors, including non-small cell lung cancer (NSCLC), colorectal cancer, and pancreatic cancer, specifically in patients with KRAS p.G12C mutations. It is also being evaluated in healthy subjects for food effect and mass balance studies.
JAB 21822 targets the KRAS p.G12C mutation, a specific genetic alteration found in certain cancers. By targeting this mutation, the drug aims to inhibit tumor growth in cancers that harbor this alteration, such as NSCLC, colorectal cancer, and pancreatic cancer.
JAB 21822 is being developed by ArriVent BioPharma, Inc., a company traded under the ticker symbol AVBP. The drug is currently in clinical trials, with studies being conducted in China.
JAB 21822 is in Phase 1 and Phase 2 clinical trials. It is an investigational drug and has not been approved by regulatory authorities. The trials are actively recruiting or have completed recruitment, with a total of 392 participants enrolled across studies.
JAB 21822 is being studied in several clinical trials, including NCT05009329 for advanced solid tumors with KRAS p.G12C, NCT05276726 for NSCLC with KRAS p.G12C and STK11 co-mutation, NCT05288205 combining JAB-21822 with JAB-3312, and NCT06008288 for pancreatic cancer and other solid tumors.
Yes, JAB 21822 and JAB-21822 refer to the same drug. The name is written with or without a hyphen, but both denote the same investigational small molecule being developed by ArriVent BioPharma for cancers with KRAS p.G12C mutations.