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Monoclonal Antibodies

JAB-30355 for Solid Tumors

Phase 1 & 2
Recruiting
Research Sponsored by Jacobio Pharmaceuticals Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have documentation of confirmed TP53 Y220C mutation.
Participant must be ≥18 years of age at the time of signing the Informed Consent Form (ICF).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately three years
Awards & highlights
No Placebo-Only Group

Summary

"This trial will test whether JAB-30355 is effective and safe for adults with advanced solid tumors that have a specific TP53 Y220C mutation."

Who is the study for?
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).
What is being tested?
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.
What are the potential side effects?
While the exact side effects are not listed here, common ones for cancer treatments like JAB-30355 may include nausea, fatigue, risk of infection, liver issues, changes in blood counts or reactions at the drug administration site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has a specific TP53 Y220C genetic mutation.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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I can swallow and keep down pills.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately three years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately three years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose limiting toxicity (DLT)
Number of participants with adverse events
Secondary study objectives
Duration of response (DOR)
Objective response rate (ORR)
Peak Plasma Concentration (Cmax)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose expansion phaseExperimental Treatment1 Intervention
Dose Expansion Phase will explore JAB-30355's clinical benefit and optimal tolerability in selected dose level.
Group II: Dose escalation phaseExperimental Treatment1 Intervention
Multiple dose levels of JAB-30355 will be explored to determine the maximum tolerated dose (MTD)

Find a Location

Who is running the clinical trial?

Jacobio Pharmaceuticals Co., Ltd.Lead Sponsor
20 Previous Clinical Trials
2,015 Total Patients Enrolled
~96 spots leftby Jan 2027
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