UnknownPhase 1

Phase I Clinical Trial in Chinese Patients of Advanced and (or) Recurrent Solid Tumor/Lymphoma

China72 participantsStarted 2017-10-19

Plain-language summary

With open, single/ multiple dosing and dose escalation, phase I clinical trial scheme to evaluate safety, tolerance and pharmacokinetic properties of Genolimzumab injection in Chinese patients of advanced and (or) recurrent solid tumor/lymphoma

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 1\. Age: 18-65. Unisex. * 2\. Understand trial procedure and content and sign informed consent voluntarily; * 3\. Patients of advanced (phase Ⅲb, multidisciplinary treatment is not appropriate), metastatic (phase IV) or recurrent solid tumor (including melanoma, NSCLC, renal cell carcinoma, head \& neck cancer, esophagus cancer, liver cancer, bladder cancer, spongioblastoma) or lymphoma (classical hodgkin lymphoma and (or) peripheral T-cell lymphoma, natural killer (NK)-T cell lymphoma and mediastinal B cell lymphoma) conformed by histology or cytology and cannot be cured by surgery. There is no effective standard treatment now. * 4\. Agree to provide recorded tumor tissue sample or fresh tissue sample. * 5\. Eastern Cooperative Oncology Group (ECOG): 0-1; * 6\. Expected life ≥ 3 months; * 7\. With at least one measurable and evaluable tumor (solid tumor is subject to criteria for evaluating efficacy of Immune-Related Response Criteria (irRC)/RECIST and lymphoma is subject to criteria/revised criteria of international working group); * 8\. Chemotherapy of the whole body is completed at least 4 weeks before inclusion. * 9\. Radiotherapy of the whole body and partial palliative radiotherapy are completed at least 4 weeks before inclusion. * 10\. Corticosteroids (prednisone\>10mg/d or equivalent) has been stopped at least 2 weeks before inclusion. * 11\. Autotransplantation is completed at least 3 months before inclusion. * 12\. Major surgeries with the ne…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

adverse event

Timeframe: all adverse events will be recorded from the time the consent form is signed through 30 days following cessation of treatment.

Serious Adverse Event

Timeframe: all serious adverse events will be recorded from the time the consent form is signed through 30 days following cessation of treatment.

Dose limiting Toxicity, DLT

Timeframe: Day 1 to Day 28 after first dose

Maximum Tolerated Dose, MTD

Timeframe: Day 1 to Day 28 after first dose

Trial details

NCT IDNCT03374007

SponsorGenor Biopharma Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-06

Contact for this trial

Shawn Yu, Master

86-010-65260820 shawn.yu@genorbio.com

View on ClinicalTrials.gov More Advanced Solid Tumor trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

adverse event

Timeframe: all adverse events will be recorded from the time the consent form is signed through 30 days following cessation of treatment.

Serious Adverse Event

Timeframe: all serious adverse events will be recorded from the time the consent form is signed through 30 days following cessation of treatment.

Dose limiting Toxicity, DLT

Timeframe: Day 1 to Day 28 after first dose

Maximum Tolerated Dose, MTD

Timeframe: Day 1 to Day 28 after first dose