CompletedPhase 1/2

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

United States39 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 range18 Years

SexALL

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.
✕. Toxicities (except alopecia \& fatigue) due to prior antitumor therapy are greater than CTCAE v5.0 Grade 1.
✕. Toxicities due to prior radiotherapy that have not resolved to Grade ≤ 1 CTCAE v5.0 at least 21 days prior to the first treatment.
✕. Untreated, unstable or uncontrolled central nervous system (CNS) metastases.
✕. Any other type of anti-cancer therapy within 21 days of the first dose of study treatment. Use of any other type of anti-cancer treatment is prohibited throughout the study.
✕. Patients with increased bleeding risk.
✕. Presence of severe cardiac dysfunction.
✕. Pulmonary embolism or deep vein thrombosis within 3 months prior to the first dose of study drug.

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

SponsorShanghai Miracogen Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-20

View on ClinicalTrials.gov More Advanced or Metastatic Solid Tumors trials

Who can participate

Age range18 Years

SexALL

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.
✕. Toxicities (except alopecia \& fatigue) due to prior antitumor therapy are greater than CTCAE v5.0 Grade 1.
✕. Toxicities due to prior radiotherapy that have not resolved to Grade ≤ 1 CTCAE v5.0 at least 21 days prior to the first treatment.
✕. Untreated, unstable or uncontrolled central nervous system (CNS) metastases.
✕. Any other type of anti-cancer therapy within 21 days of the first dose of study treatment. Use of any other type of anti-cancer treatment is prohibited throughout the study.
✕. Patients with increased bleeding risk.
✕. Presence of severe cardiac dysfunction.
✕. Pulmonary embolism or deep vein thrombosis within 3 months prior to the first dose of study drug.

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