Actively Recruiting
Evaluate the Safety and Tolerability of JCXH-212 Monotherapy and Combined With Toripalimab in the Treatment of Malignant Solid Tumors
Led by Peking University Cancer Hospital & Institute · Updated on 2024-05-14
24
Participants Needed
1
Research Sites
220 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the safety and tolerability of JCXH-212 monotherapy and combined with Toripalimab in patients with malignant solid tumors; to determine the maximum tolerated dose (MTD), and to evaluate the dose-limiting toxicity (DLT) of JCXH-212 monotherapy and combined with Toripalimab.
CONDITIONS
Official Title
Evaluate the Safety and Tolerability of JCXH-212 Monotherapy and Combined With Toripalimab in the Treatment of Malignant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 to 75 years
- Patients with advanced malignant solid tumors who have failed standard treatment (for Part 1)
- For Part 2: patients with initial treatment refusing or intolerant of standard treatment with PD-L1 TPS 61%; or stage IIIB-IV with progression after prior treatment; or stage II-III NSCLC after surgery and chemotherapy intending immunotherapy
- Ability to provide tumor biopsy tissue samples for neoantigen detection
- ECOG performance status of 0 to 1
- Expected survival time of more than 3 months
- At least one measurable tumor lesion meeting size criteria by RECIST v1.1
- Adequate bone marrow, liver, kidney function, and coagulation parameters
- Tumor tissue gene detection shows positive tumor neoantigen expression
- No brain metastasis or stable/asymptomatic brain metastasis after treatment over 4 weeks
- Adverse reactions from prior treatment recovered to grade 0-1 except alopecia and vitiligo within 4 weeks
- Voluntary informed consent and expected compliance
You will not qualify if you...
- Known or suspected allergy to study drug ingredients or analogues
- For Part 2: history of severe immune checkpoint inhibitor adverse reactions (grade 63) except certain skin reactions or hypothyroidism
- Unstable or serious medical conditions affecting safety or compliance
- Significant cardiovascular or cerebrovascular disease or ECG abnormalities
- Active second primary malignant tumor within 2 years except certain treated cancers
- Uncontrollable malignant third space effusion
- Positive pregnancy test in women of childbearing potential
- Major surgery within 4 weeks before first dose
- Insufficient washout period from prior anti-cancer treatments
- Serious acute or chronic diseases or lab abnormalities increasing risk
- Active or history of autoimmune diseases with relapse risk excluding some controlled conditions
- Active infections including HIV, syphilis, hepatitis B or C; chronic asymptomatic carriers excluded
- Active infection requiring treatment
- History of organ transplantation
- Primary immunodeficiency disorders
- Use of immunosuppressive drugs within 7 days before first dose except limited corticosteroid use
- Investigator judgment deeming patient unsuitable for trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, China, 100042
Actively Recruiting
Research Team
Z
Zhuo Minglei, Physician
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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