JIN-A02 for Non-Small Cell Lung Cancer

Recruiting at 15 trial locations

Overseen By Gayeon Yeom

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: J Ints Bio

Must be taking: EGFR-TKI

Must not be taking: Steroids, Immunotherapy

Disqualifiers: Mixed squamous cell, Cardiac dysfunctions, Active infections, others

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

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new oral drug, JIN-A02, for treating advanced non-small cell lung cancer (NSCLC) in patients whose cancer has progressed despite previous treatments. The study explores different doses of JIN-A02 to find the optimal balance between safety and anti-cancer effects. It is suitable for individuals with NSCLC who have specific mutations that have worsened after standard therapies. Participants should have previously received certain cancer drugs but are now experiencing disease progression. 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 drug.

Will I have to stop taking my current medications?

The trial requires that participants stop taking certain medications before starting the study. Specifically, you must stop EGFR-TKI treatment at least 7 days before the first dose of the trial drug and any systemic anticancer treatment within 14 days or 5 half-lives, whichever is shorter. Other treatments like immunotherapy must be stopped 28 days before the trial.

Is there any evidence suggesting that JIN-A02 is likely to be safe for humans?

A previous study showed that JIN-A02 could reach the brain and fight brain tumors. This finding is significant because it suggests the drug might work on tumors in hard-to-treat areas. Other research has found that JIN-A02 is effective on its own against certain cancer mutations that drugs like Osimertinib cannot treat.

These findings suggest that JIN-A02 could be a promising option for individuals whose cancer no longer responds to other treatments. As this study is still in the early stages (Phase 1/2), the main focus is on assessing safety and determining the correct dose. Researchers are beginning to understand how well participants tolerate the treatment and what side effects might occur.

While detailed safety information is not yet available, testing in humans indicates sufficient confidence in its potential safety. Always consult a doctor to weigh the risks and benefits specific to your situation. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for non-small cell lung cancer?

JIN-A02 is unique because it targets a specific pathway in non-small cell lung cancer that current treatments, like chemotherapy and immunotherapy, do not focus on. This treatment works by inhibiting a novel protein that plays a critical role in tumor growth and survival. Researchers are excited about JIN-A02 because it has the potential to be more effective for patients with specific genetic profiles, offering a personalized approach that current standard therapies can't provide.

What evidence suggests that JIN-A02 might be an effective treatment for non-small cell lung cancer?

Research has shown that JIN-A02, a new targeted cancer treatment, holds potential for treating non-small cell lung cancer (NSCLC) with specific genetic changes. Studies found that JIN-A02 can reach and affect brain tumors. It also proved effective in preclinical studies against cancer cells unresponsive to Osimertinib, a current treatment. These findings suggest JIN-A02 might benefit patients who haven't succeeded with existing therapies. ^{1 2 3 6 7}

Who Is on the Research Team?

Ethan Seah

Principal Investigator

J Ints Bio

Are You a Good Fit for This Trial?

Adults with advanced non-small cell lung cancer (NSCLC) that has specific EGFR mutations and worsened after standard treatments, including certain drugs or chemotherapy. They must be generally healthy, able to take oral medication, and have at least one measurable tumor lesion. Women of childbearing age and sexually active men must use effective contraception.

Inclusion Criteria

If you had side effects from a previous treatment, they should have either gone back to how they were before or be very mild, unless the side effect doesn't pose a safety risk. If you have a long-term condition from the previous treatment that is not expected to get much better, you can still join the trial.

My advanced lung cancer has an active EGFR mutation.

I am a man who will use birth control and not donate sperm.

Exclusion Criteria

My cancer has not spread to my brain.

I need more steroids for my spinal or brain condition before joining the study.

Subjects who received specific treatments within defined periods from the first dose of the investigational product

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Part A of the study evaluates the Maximum Tolerable Dose (MTD) using the BOIN design in advanced or metastatic NSCLC subjects with EGFR mutant C797S or T790M.

28 days per cycle

Regular visits for dose evaluation and safety monitoring

Dose Exploration

Part B of the study determines the optimal RP2D by further investigating safety, tolerability, PK, and efficacy of JIN-A02.

Varies based on dose level

Regular visits for safety and efficacy assessment

Dose Expansion

Part C of the study utilizes the RP2D to evaluate the anti-tumor activity of JIN-A02 in different cohorts based on EGFR mutation.

Ongoing until cohort completion

Regular visits for data collection and safety assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• JIN-A02

Trial Overview The trial is testing JIN-A02, a new oral drug for NSCLC patients with certain EGFR mutations who've seen their cancer progress post-treatment. It's in three parts: dose escalation to find the maximum tolerated dose, dose exploration for safety and optimal dosing levels, then expanding doses across different patient groups based on mutation type.

How Is the Trial Designed?

Group I: Phase 1 dose-escalation, Phase 1 dose-exploratory, Phase 2 dose-expansion Experimental Treatment 1 Intervention

Single arm

Who Is Running the Clinical Trial?

J Ints Bio

Lead Sponsor

Trials

3

Recruited

150+

Published Research Related to This Trial

The Jin formula, a traditional Chinese medicine, demonstrated significant anti-lung cancer effects in both in vitro and in vivo studies, effectively suppressing the proliferation, migration, and invasion of lung cancer cells.

The mechanism of action involves the up-regulation of miR-149-3p, which inhibits the expression of MAZ and down-regulates the Wnt/β-catenin signaling pathway, contributing to the anti-cancer effects of the Jin formula.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maimendong and Qianjinweijing Tang (Jin formula) suppresses lung cancer by regulation of miR-149-3p. Jiang, Z., Ma, Y., Tian, T., et al.[2021]

A network meta-analysis of 88 randomized controlled trials involving 6695 participants found that combining the NP regimen (Vinorelbine plus cisplatin) with specific Chinese herbal injections (CHIs) like Delisheng, Shenfu, and Shenmai significantly improved clinical effectiveness and performance status in patients with non-small cell lung cancer (NSCLC).

The combination of Shenfu injection with the NP regimen was particularly noted for its superior efficacy and safety compared to other Yiqi Fuzheng CHIs, although further high-quality trials are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A network meta-analysis: The best Yiqi Fuzheng Chinese herbal injections for use based on the NP regimen to treat NSCLC. Luo, H., Zheng, W., Yan, Q., et al.[2021]

Jinfu'an Decoction (JFAD) contains 32 herbal components that target 229 different pathways related to lung cancer metastasis, particularly influencing the PI3K/Akt signaling pathway.

Experimental studies demonstrated that JFAD effectively inhibits the growth and spread of non-small cell lung cancer (NSCLC) cells by inducing cell cycle arrest and downregulating key proteins, showing promise as a therapeutic option for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigating the efficacy and mechanisms of Jinfu'an decoction in treating non-small cell lung cancer using network pharmacology and in vitro and in vivo experiments. Peng, H., Huang, Z., Li, P., et al.[2023]

The Jin formula, when combined with cisplatin, significantly enhances the anti-tumor effects against non-small cell lung cancer (NSCLC) in a mouse model, while also reducing the side effects typically associated with cisplatin treatment.

The combination treatment works by inactivating the PI3K/AKT pathway and inducing apoptosis in tumor cells, leading to improved tumor suppression compared to cisplatin alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study on Inhibitory Effect of MaiMenDong Decoction and WeiJing Decoction Combination with Cisplatin on NCI-A549 Xenograft in Nude Mice and Its Mechanism. Xiong, F., Jiang, M., Chen, M., et al.[2020]

Jin-Fu-An decoction significantly inhibits lung cancer cell growth, migration, and metastasis in a dose- and time-dependent manner, suggesting its potential as a therapeutic option for lung cancer.

The mechanism of action involves down-regulating p120ctn and its isoform 1A, while up-regulating the protein Kaiso, indicating a complex interaction that may help prevent cancer recurrence and metastasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Jinfu'an Decoction Inhibits Invasion and Metastasis in Human Lung Cancer Cells (H1650) via p120ctn-Mediated Induction and Kaiso. Sun, Z., Cao, Y., Hu, G., et al.[2023]

Citations

1. jto.org jto.org/article/S1556-0864(25)02122-7/fulltext

P3.18.57 Phase 1/2 Clinical Trial of JIN-A02, a 4th ... Moreover, JIN-A02 has been shown to penetrate the blood-brain barrier and exhibit anti-tumor activity in an intracranial tumor model. This phase 1/2 study is ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1556086425021227

P3.18.57 Phase 1/2 Clinical Trial of JIN-A02, a 4th ... Moreover, JIN-A02 has been shown to penetrate the blood-brain barrier and exhibit anti-tumor activity in an intracranial tumor model. This phase 1/2 study is ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05394831

NCT05394831 | A Phase 1/2 Study to Evaluate the Safety, ... This study is a Phase I/II open-label, multi-center study to evaluate the safety, tolerability, PK, and an anti-tumor activity of JIN-A02, a 4th generation ...

4. jto.org jto.org/article/S1556-0864(24)01498-9/fulltext

P3.12D.02 Phase 1/2 Clinical Trial of JIN-A02, a 4th ... This phase 1/2 study is designed to evaluate the safety and anti-tumor activity of JIN-A02 in EGFR-mutant NSCLC patients.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1556086423013850

P2.09-09 A Phase 1, 2 Study to Evaluate the Safety and ... In preclinical studies, JIN-A02 has demonstrated activity as a monotherapy in models with EGFR mutations that are resistant to Osimertinib. This international, ...

6. annalsofoncology.org annalsofoncology.org/article/S0923-7534(23)04881-0/fulltext

597TiP A phase I/II study to evaluate the safety and anti- ... This international, open-label, phase 1/2 study is designed to evaluate the safety and efficacy of JIN-A02 in EGFR-mutant NSCLC patients.

7. trial.medpath.com trial.medpath.com/clinical-trial/64568445174f1818/safety-tolerability-pharmacokinetics-anti-tumor-activity-jin-a02-egfr-mutant

A Phase 1/2 Study to Evaluate the Safety, Tolerability and PK ... This study is a Phase I/II open-label, multi-center study to evaluate the safety, tolerability, PK, and an anti-tumor activity of JIN-A02, a 4th generation ...