JAB-30355 for Solid Tumors

Recruiting at 11 trial locations

Overseen By Jacobio Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Jacobio Pharmaceuticals Co., Ltd.

Disqualifiers: Brain metastases, CNS tumor, Infection, others

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

Compensation: Varies

Number of Visits: Unknown

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a new treatment, JAB-30355, for adults with advanced solid tumors that have a specific genetic change called the TP53 Y220C mutation. The trial will explore different doses to identify the safest and most effective one. Individuals who have already tried at least one cancer treatment and have this specific genetic mutation are suitable candidates. Those with advanced cancer and this mutation, for whom previous treatments have not been successful, might consider this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether 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-30355 is likely to be safe for humans?

Research has shown that JAB-30355 is being tested for safety in individuals with advanced solid tumors, specifically those with a TP53 Y220C mutation. While specific results from participants are not yet available, the trial aims to determine the safest and most effective dose of JAB-30355.

As the trial is in its early stages, researchers are actively collecting safety information. They are closely monitoring participants' tolerance to the treatment and observing any side effects. Although experiences may vary among participants, the goal is to identify the dose that provides the best results with the fewest side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for solid tumors, like chemotherapy and radiation, work by attacking rapidly dividing cells, which can affect both cancerous and healthy cells. But JAB-30355 is different because it targets specific pathways in tumor cells, potentially leading to fewer side effects. Researchers are excited about JAB-30355 because it not only aims to maximize effectiveness by honing in on these pathways, but also explores different dosing strategies to find the most tolerable and beneficial levels for patients. This precise targeting and tailored dosing could make it a game-changer in cancer treatment.

What evidence suggests that JAB-30355 might be an effective treatment for solid tumors?

Research has shown that JAB-30355 could be promising for treating advanced solid tumors with the TP53 Y220C mutation. In studies, JAB-30355 performed better at higher doses, with effects increasing as the dose increased. This trial includes a dose escalation phase to explore multiple dose levels of JAB-30355 and determine the maximum tolerated dose (MTD). In various early tests, the treatment stopped tumor growth or even shrank tumors. These results suggest that JAB-30355 might effectively target specific cancer mutations. While more research is needed, the initial findings are encouraging for those with the TP53 Y220C mutation. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

Adults over 18 with advanced solid tumors that have a specific genetic change called TP53 Y220C can join. They must have at least one tumor that can be measured, good blood and organ function, and be able to take pills. Participants should have tried at least one other treatment before and be fairly active (ECOG score of 0 or 1).

Inclusion Criteria

I have at least one tumor that can be measured.

My cancer has a specific TP53 Y220C genetic mutation.

I am fully active or can carry out light work.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Multiple dose levels of JAB-30355 will be explored to determine the maximum tolerated dose (MTD)

Approximately 1 year

Dose Expansion

Further exploration of JAB-30355's clinical benefit and tolerability in selected dose levels

Approximately 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• JAB-30355

Trial Overview The trial is testing JAB-30355's effectiveness and safety in treating these tumors. It aims to see how well this new medication works for patients who carry the TP53 Y220C mutation.

How Is the Trial Designed?

Group I: Dose expansion phase Experimental Treatment 1 Intervention

Dose Expansion Phase will explore JAB-30355's clinical benefit and optimal tolerability in selected dose level.

Group II: Dose escalation phase Experimental Treatment 1 Intervention

Multiple dose levels of JAB-30355 will be explored to determine the maximum tolerated dose (MTD)

Who Is Running the Clinical Trial?

Jacobio Pharmaceuticals Co., Ltd.

Lead Sponsor

Trials

21

Recruited

2,300+

Published Research Related to This Trial

A meta-analysis of 27 studies involving 2609 cancer patients found that high levels of Jab1 expression are significantly associated with poor overall survival, indicating its potential role as a prognostic marker.

High Jab1 expression correlates with advanced cancer features such as clinical stage, lymphatic metastasis, and distant metastasis, suggesting it may contribute to cancer progression and could be targeted for therapeutic strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic role of c-Jun activation domain-binding protein-1 in cancer: A systematic review and meta-analysis. Shi, D., Mu, S., Hu, B., et al.[2021]

In a study of 80 colorectal carcinoma (CRC) cases, Jab1 protein was found to be highly expressed in cancerous tissues (96.3% positive rate), indicating its potential role in the development of CRC.

The expression of Jab1 was significantly associated with important clinical features such as tumor differentiation, invasion depth, TNM stage, and lymph node metastasis, suggesting it could serve as a valuable diagnostic marker and therapeutic target for CRC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Expression and significance of c-Jun activation domain binding protein 1 in human colorectal carcinoma]. Guo, Z., Lü, Q., Zhang, Y., et al.[2017]

The study identifies Stat3 as an upstream regulator of Jab1/Csn5 expression in nasopharyngeal carcinoma (NPC), which contributes to the cancer's resistance to cisplatin treatment.

Silencing Stat3 in tumors reduces Jab1/Csn5 levels, making NPC cells more sensitive to cisplatin-induced apoptosis, suggesting that targeting this signaling pathway could improve treatment outcomes in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stat3 contributes to cancer progression by regulating Jab1/Csn5 expression. Pan, Y., Wang, S., Su, B., et al.[2019]

Jab1/CSN5 protein is overexpressed in nasopharyngeal carcinoma (NPC) cell lines that are resistant to cisplatin and other DNA-damaging treatments, indicating its role in treatment resistance.

Knocking down Jab1 expression increases sensitivity to cisplatin and radiation, while enhancing Jab1 levels boosts resistance, suggesting that Jab1 regulates the DNA repair protein Rad51 and could serve as a biomarker for predicting treatment outcomes in NPC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suppression of Jab1/CSN5 induces radio- and chemo-sensitivity in nasopharyngeal carcinoma through changes to the DNA damage and repair pathways. Pan, Y., Zhang, Q., Atsaves, V., et al.[2021]

Jab1/COPS5 is identified as a high-risk gene associated with poor prognosis in various cancers, based on analysis of large clinical datasets including TCGA, GEO, and CPTAC, indicating its potential as a biomarker for cancer progression.

The study found that Jab1/COPS5 expression correlates with immune cell infiltration in certain tumors, suggesting it may play a role in the tumor microenvironment and could be targeted for therapeutic interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pan-cancer analyses of Jab1/COPS5 reveal oncogenic role and clinical outcome in human cancer. Wang, L., Zeng, X., Yang, G., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06386146

JAB-30355 in Patients With Advanced Solid Tumors ... This study is to evaluate the efficacy and safety of JAB-30355 in adult participants with advanced solid tumors harboring TP53 Y220C mutation. Detailed ...

2. aacrjournals.org aacrjournals.org/cancerres/article/84/6_Supplement/5940/739786/Abstract-5940-JAB-30355-A-highly-potent-orally

Abstract 5940: JAB-30355: A highly potent, orally bioavailable ... Furthermore, JAB-30355 exhibited dose-dependent anti-tumor activity, inducing tumor stasis or regression in multiple CDX and PDX models of ...

3. my.clevelandclinic.org my.clevelandclinic.org/clinical-trials/2117-a-phase-12a-multi-center-open-label-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-preliminary-evidence-of-antitumor-activity-of-jab-30355-in-adult-patients-with-advanced-solid-tumors-harboring-tp53-y220c-mutation

Clinical Trials To evaluate preliminary antitumor activity of various dose levels JAB-30355 monotherapy in participants with advanced solid tumors harboring TP53 Y220C mutation ...

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

Jacobio 2023 Annual Presentation JAB-8263 is well tolerated in patients with solid tumors and hematological malignancies. Most TRAEs were G1 and G2. ○. Clinical benefits of JAB-8263 monotherapy ...

5. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/480076

JAB-30355 in Patients With Advanced Solid Tumors ... This study is to evaluate the efficacy and safety of JAB-30355 in adult participants with advanced solid tumors harboring TP53 Y220C mutation. Fill out a short ...

6. jacobiopharma.com jacobiopharma.com/sites/default/files/science/JAB-30355%20a%20highly%20potent%2C%20orally%20bioavailable%20p53%20Y220C%20reactivator.pdf

JAB-30355: a highly potent, orally bioavailable p53 Y220C ... JAB-30355 exhibited dose-dependent anti-tumor activity, inducing tumor stasis or regression in multiple CDX and PDX models of ovarian cancer, pancreatic cancer, ...

7. synapse.patsnap.com synapse.patsnap.com/drug/d5449ab077c6483b87a8f0816eb3cfac

JAB-30355 - Drug Targets, Indications, Patents A Phase 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of ...