CompletedPhase 1/2

A Study of MRG004A in Patients With Tissue Factor Positive Advanced or Metastatic Solid Tumors

United States, China39 participantsStarted 2021-07-26

Plain-language summary

The objective of this study is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of MRG004A in patients with Tissue Factor positive advanced or metastatic 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

. Understands and provides written informed consent and willing to follow the requirements specified in protocol.
. Age ≥18 years.
. Life expectancy ≥6 months.
. For Part B patients, documented Tissue Factor (TF) presence in tumor biopsy specimens obtained from archival or re-biopsy specimens by immunohistochemistry (IHC) protein expression.
. Must have histologically or cytologically confirmed unresectable or metastatic cancer with documented disease progression during prior therapy, or relapse or progression following approved standard therapy for their tumor types- Part A and Part B.
. Part B: Patients who have documented progression during or relapse following standard therapy, no further treatment options that are known to improve survival, and participation in a clinical trial is a reasonable therapeutic option.
. Patients must have measurable disease per RECIST v1.1.
. ECOG performance status of 0 or 1.

Exclusion criteria

. Archival or biopsy tumor shows TF IHC membrane or cytosolic score of zero, no TF-positive expression or no TF-positive staining in Part B patients.

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

Maximum Tolerated Dose (MTD)

Timeframe: DLT will be evaluated during the first treatment cycle (Day 1-21)

Recommended Phase II Dose (RP2D)

Timeframe: Baseline to study completion (up to 24 months)

Objective Response Rate (ORR)

Timeframe: Baseline to study completion (up to 24 months)

Adverse Events (AEs)

Timeframe: From signing informed consent until 45 days after the last dose of MRG004A

Trial details

NCT IDNCT04843709

SponsorLepu Biopharma Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-20

View on ClinicalTrials.gov More Advanced or Metastatic Solid Tumors 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

. Understands and provides written informed consent and willing to follow the requirements specified in protocol.
. Age ≥18 years.
. Life expectancy ≥6 months.
. For Part B patients, documented Tissue Factor (TF) presence in tumor biopsy specimens obtained from archival or re-biopsy specimens by immunohistochemistry (IHC) protein expression.
. Must have histologically or cytologically confirmed unresectable or metastatic cancer with documented disease progression during prior therapy, or relapse or progression following approved standard therapy for their tumor types- Part A and Part B.
. Part B: Patients who have documented progression during or relapse following standard therapy, no further treatment options that are known to improve survival, and participation in a clinical trial is a reasonable therapeutic option.
. Patients must have measurable disease per RECIST v1.1.
. ECOG performance status of 0 or 1.

Exclusion criteria

. Archival or biopsy tumor shows TF IHC membrane or cytosolic score of zero, no TF-positive expression or no TF-positive staining in Part B patients.

What they're measuring

Maximum Tolerated Dose (MTD)

Timeframe: DLT will be evaluated during the first treatment cycle (Day 1-21)

Recommended Phase II Dose (RP2D)

Timeframe: Baseline to study completion (up to 24 months)

Objective Response Rate (ORR)

Timeframe: Baseline to study completion (up to 24 months)

Adverse Events (AEs)

Timeframe: From signing informed consent until 45 days after the last dose of MRG004A