JAB-23E73 for Cancer

Recruiting at 4 trial locations

Overseen By Jacobio Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Jacobio Pharmaceuticals Co., Ltd.

Must not be taking: KRAS inhibitors

Disqualifiers: CNS tumors, QT interval >470, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

294 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called JAB-23E73 to determine its safety and tolerability in people with advanced solid tumors (cancer that has spread and cannot be cured). The trial consists of different parts: initially, it assesses the maximum safe dosage; subsequently, it evaluates the treatment's effectiveness in specific cancer types, such as lung and colorectal cancer. Individuals with advanced cancer, who are no longer eligible for surgery and have specific changes in the KRAS gene, might be suitable candidates for this study. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that JAB-23E73 is likely to be safe for humans?

Research has shown that JAB-23E73 is in the early stages of testing to assess its safety for people with cancer. JAB-23E73 is an experimental drug designed to target specific cancer cells. In lab studies, it effectively targeted cancer cells while sparing healthy ones. However, information from human studies remains limited due to the early stage of testing.

This limitation means safety information is scarce. Early trials primarily focus on safety and determining the correct dose. As JAB-23E73 begins human trials, researchers continue to learn about its side effects and how well people tolerate it. Like many new treatments, unknown risks may emerge as more people participate.

Prospective participants should note that these trials are carefully monitored. The primary goal is to ensure the treatment is safe and tolerable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about JAB-23E73 because it targets cancers with KRAS mutations, which are often difficult to treat with current options. Unlike traditional chemotherapy that attacks all rapidly dividing cells, JAB-23E73 is designed to specifically target and inhibit the KRAS protein, which plays a key role in the growth of certain tumors. This precision could mean fewer side effects and improved effectiveness for patients with KRAS-altered non-small cell lung cancer (NSCLC) and other challenging tumors. Additionally, the potential to determine an optimal dosage through dose escalation and expansion phases may lead to more personalized and effective treatment plans.

What evidence suggests that JAB-23E73 might be an effective treatment for advanced solid tumors?

Research has shown that JAB-23E73 may help treat advanced solid tumors. In early tests with mice, JAB-23E73 shrank tumors without causing major side effects. This trial includes several phases to evaluate JAB-23E73: the Dose Escalation Phase (Phase 1a) assesses safety and tolerability, the Dose Expansion/Optimization Phase (Phase 1b) determines the recommended dose in patients with KRAS-altered NSCLC or other selected tumors, and the Indication Expansion Phase (Phase 2a) evaluates its antitumor activity in advanced or metastatic cancers. Although human studies provide limited information, early results suggest that JAB-23E73 could be effective against these challenging cancers, offering hope for people with conditions like advanced non-small cell lung cancer (NSCLC). ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

Adults with advanced solid tumors that can't be cured by surgery or other treatments, who have specific changes in a gene called KRAS. They must have at least one tumor measurable by medical scans, expect to live more than 3 months, and be able to give consent. People with brain tumors, severe allergies to the study drug, heart issues, uncontrolled fluid buildup or those previously treated with similar drugs can't join.

Inclusion Criteria

Patients must have at least one measurable lesion as defined by RECIST v1.1

Written informed consent

Participants are required to provide an archived tumor sample

Exclusion Criteria

My cancer originated in the brain or spinal cord.

Known serious allergy to JAB-23E73 or excipient

QT interval >470 msec

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation (Phase 1a)

Evaluate overall safety, tolerability, and determine the maximum tolerated dose (MTD) of JAB-23E73 monotherapy

Up to 1 year

Dose Expansion / Optimization (Phase 1b)

Determine the recommended Phase 2 dose (RP2D) of JAB-23E73 in patients with KRAS-altered NSCLC or other selected tumors

Up to 2 years

Indication Expansion (Phase 2a)

Evaluate the preliminary antitumor activity of JAB-23E73 monotherapy at the RP2D in patients with advanced or metastatic CRC, PDAC, and other solid tumors

Up to 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• JAB-23E73

Trial Overview The trial is testing JAB-23E73's safety and how well people tolerate it when given to adults with advanced solid tumors that have a KRAS alteration. The main goal is to see if this new treatment is safe and what effects it has on these types of cancers.

How Is the Trial Designed?

Group I: Indication Expansion (Phase 2a) Experimental Treatment 1 Intervention

Evaluate the preliminary antitumor activity of JAB-23E73 monotherapy at the RP2D in patients with advanced or metastatic CRC, PDAC, and other solid tumors.

Group II: Dose Expansion / Optimization Phase (Phase 1b) Experimental Treatment 1 Intervention

Determine RP2D of JAB-23E73 in patients with KRAS-alternated NSCLC or other selected tumors

Group III: Dose Escalation (Phase 1a) Experimental Treatment 1 Intervention

Evaluate overall Safety, tolerability, and determine MTD of JAB-23E73 monotherapy.

Who Is Running the Clinical Trial?

Jacobio Pharmaceuticals Co., Ltd.

Lead Sponsor

Trials

21

Recruited

2,300+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06973564

JAB-23E73 in Adult Participants With Advanced Solid ... Dose Expansion/Optimization (Phase 1b): Determine the RP2D of JAB-23E73 in patients with KRAS- alternated NSCLC or other selected tumors. RP2D determined by MTD ...

2. prnewswire.com prnewswire.com/news-releases/jacobio-presents-pre-clinical-data-of-pan-kras-inhibitor-jab-23e73-at-aacr-nci-eortc-international-conference-302592811.html

Jacobio Presents Pre-Clinical Data of Pan-KRAS Inhibitor ... In KRAS-driven mouse tumor models, JAB-23E73 induced tumor regression without causing significant body weight loss, indicating good tolerability ...

3. clin.larvol.com clin.larvol.com/trial-detail/NCT06973564

JAB-23E73 in Adult Participants With Advanced Solid ... Indication Expansion (Phase 2a): Evaluate the preliminary antitumor activity of JAB-23E73 monotherapy at the RP2D in patients with advanced or metastatic CRC, ...

4. jacobiopharma.com jacobiopharma.com/sites/default/files/pdfs/Jacobio%20Corporate%20Presentation%20FY%202023-0407.pdf

Jacobio 2023 Annual Presentation When given at 1/10 dose of BMS-986158, JAB-8263 showed equivalent anti- tumor efficacy in AML, MM, and SCLC xenograft models. Clinical study. ○. JAB-8263 is ...

5. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/604675

A Phase I/IIa Study of JAB-23E73 in Patients With ... This is a multicenter, open-label, phase I/IIa to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, ...

6. my.clevelandclinic.org my.clevelandclinic.org/clinical-trials/2273-a-phase-12a-multicenter-open-label-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-preliminary-anti-tumor-activity-of-jab-23e73-in-adult-participants-with-advanced-solid-tumors-with-kras-alteration

Clinical Trials A Phase 1/2a, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of JAB-23E73 in ...