CompletedPhase 1

A Study to Assess LBL-007 in Combination With Toripalimab and Axitinib Tablets Subjects With Advanced Melanoma

China79 participantsStarted 2020-05-12

Plain-language summary

A phase I clinical study evaluating LBL-007 in the treatment of subjects with advanced solid tumors

Who can participate

Age range

18 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

. Willingness to provide written informed consent and follow the study treatment plan and visit plan;
. Aged ≥ 18 years at time of signing informed consent, male or female;
. Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1;
. Have life expectancy of at least 12 weeks ;
. Subject with at least one measurable tumor lesion,according to the evaluation standard of solid tumor efficacy (RECIST 1.1).

Exclusion criteria

. Subjects are allergic to LBL-007, PD-1 and similar compounds or any component in the prescription;
. Subjects with active central nervous system metastases (regardless of whether they have received treatment), including symptomatic brain metastases, meningeal metastases, or spinal cord compression, but asymptomatic brain metastases (no progression and/or at least 4 weeks after radiotherapy) No neurological symptoms or signs after surgical resection, and dexamethasone or mannitol treatment is not required);
. Have received major surgery within 4 weeks before the first administration;
. Subjects can not tolerate intravenous administration and have difficulty in venous blood collection (if there is a history of fainting needles and bleeding);

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

Number of subjcects with adverse events and serious adverse events

Timeframe: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (28+7 days after drug withdrawal or before the start of new anti-tumor therapy)

Maximum tolerated dose (MTD)

Timeframe: During the first two Cycles(each cycle is 14 days)

Dose-limiting toxicities (DLT)

Timeframe: During the first two Cycles(each cycle is 14 days)

Trial details

NCT IDNCT04640545

SponsorNanjing Leads Biolabs Co.,Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-19

View on ClinicalTrials.gov More Advanced Melanoma trials

Who can participate

Age range

18 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

. Willingness to provide written informed consent and follow the study treatment plan and visit plan;
. Aged ≥ 18 years at time of signing informed consent, male or female;
. Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1;
. Have life expectancy of at least 12 weeks ;
. Subject with at least one measurable tumor lesion,according to the evaluation standard of solid tumor efficacy (RECIST 1.1).

Exclusion criteria

. Subjects are allergic to LBL-007, PD-1 and similar compounds or any component in the prescription;
. Subjects with active central nervous system metastases (regardless of whether they have received treatment), including symptomatic brain metastases, meningeal metastases, or spinal cord compression, but asymptomatic brain metastases (no progression and/or at least 4 weeks after radiotherapy) No neurological symptoms or signs after surgical resection, and dexamethasone or mannitol treatment is not required);
. Have received major surgery within 4 weeks before the first administration;
. Subjects can not tolerate intravenous administration and have difficulty in venous blood collection (if there is a history of fainting needles and bleeding);

What they're measuring

Number of subjcects with adverse events and serious adverse events

Timeframe: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (28+7 days after drug withdrawal or before the start of new anti-tumor therapy)

Maximum tolerated dose (MTD)

Timeframe: During the first two Cycles(each cycle is 14 days)

Dose-limiting toxicities (DLT)

Timeframe: During the first two Cycles(each cycle is 14 days)