A Dose Escalation/Expansion Study of MDK-703 in Patients With Advanced or Metastatic Solid Tumors

NCT05716295 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: MDK-703-102
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 6

Brief Summary

This is an open-label, dose escalation and dose expansion study of MDK-703 as a monotherapy and in combination with other cancer therapies in adult study participants with advanced or metastatic solid tumors.

Conditions

Advanced or Metastatic Solid Tumors

Keywords

MDK-703; IL-7; Interleukin 7; Interleukin-7; IL7; oncology; immuno-oncology; immunotherapy; solid tumor; advanced solid tumor; metastatic solid tumor; neoplasms; solid malignancies; pancreatic cancer; PDAC; MSS-CRC; microsatellite stable CRC; microsatellite stable colorectal cancer; prostate cancer; breast cancer; ovarian cancer; immune cold

Outcome Measures

Primary Outcomes (5)

• Dose Limiting Toxicities (DLT)

  Based on toxicities observed from time of first dose through first cycle of treatment

  Assessed up to 24 months

• Maximum tolerated dose (MTD)

  Based on toxicities observed

  Assessed up to 24 months

• Optimal biological dose (OBD)

  Based on toxicities observed

  Assessed up to 24 months

• Recommended dose (RD)

  Based on toxicities observed

  Assessed up to 24 months

• Adverse events (AE)

  Incidence and severity of treatment-emergent AEs and serious AEs as assessed by CTCAE v5.0

  Assessed up to 24 months

Secondary Outcomes (8)

• Objective Response Rate (ORR)

  Assessed up to 24 months

• Duration of Response (DOR)

  Assessed up to 24 months

• Time to Response (TTR)

  Assessed up to 24 months

• Disease Control Rate (DCR)

  Assessed up to 24 months

• Progression-Free Survival (PFS)

  Assessed up to 24 months

Study Arms (2)

MDK-703 Monotherapy

EXPERIMENTAL

MDK-703 will be administered in sequential ascending doses as a monotherapy until unacceptable toxicity, disease progression, or withdrawal of consent.

Drug: MDK-703

MDK-703 in combination with a checkpoint inhibitor

EXPERIMENTAL

MDK-703 will be administered in sequential ascending doses in combination with a checkpoint inhibitor until unacceptable toxicity, disease progression, or withdrawal of consent.

Drug: MDK-703; Drug: Checkpoint Inhibitor, Immune

Interventions

MDK-703 DRUG

MDK-703 will be administered as specified under Arm description.

MDK-703 Monotherapy; MDK-703 in combination with a checkpoint inhibitor

Checkpoint Inhibitor, Immune DRUG

Checkpoint inhibitor will be administered as specified under Arm description.

MDK-703 in combination with a checkpoint inhibitor

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Measurable disease per RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate cardiovascular, hematological, liver, and renal function.
• Prior anti-cancer therapy is allowed as long as any treatment related toxicity is resolved to an appropriate level.
• Females of childbearing potential and men who are not surgically sterile must agree to use medically-accepted method of birth control during the study.
• \[Females\] Negative serum pregnancy test within 14 days prior to initiating study treatment.
• \[Males\] Agreement to refrain from donating or banking sperm during the treatment period.

You may not qualify if:

• Treated with anti-cancer therapy or an investigational agent within 2 weeks or 5 half-lives prior to first dose, whichever is shorter; or within 4 weeks for immunotherapy.
• Unresolved toxicities from prior systemic therapy greater than NCI CTCAE grade 1 at time of first dose, except alopecia, vitiligo, and grade 2 neuropathy due to prior chemotherapy.
• Radiotherapy within 14 days prior to first dose of study drug.
• Major surgery within 30 days prior to first dose of study drug, or anticipation of major surgery during study treatment.
• Active autoimmune disease requiring systemic treatment within the past 3 months or have a documented history of clinically severe autoimmune disease that requires systemic steroids or immunosuppressive agents.
• Primary central nervous system (CNS) disease or leptomeningeal disease.
• Impaired cardiovascular function or clinically significant cardiovascular disease.
• Uncontrolled diabetes mellitus or other uncontrolled immune-related endocrinopathies.
• Abnormal pulmonary function within the previous 6 months, including history of pneumonitis, active pneumonitis, interstitial lung disease requiring the use of steroids, idiopathic pulmonary fibrosis, active pleural effusion, severe dyspnea at rest or requiring supplementary oxygen therapy.
• History of allogenic, bone marrow, or solid organ transplant.
• History of cerebrovascular events within 6 months prior to first dose.
• Human immunodeficiency virus (HIV) infection or active infection with hepatitis C; uncontrolled hepatitis B infection.
• Clinically significant bleeding within 2 weeks prior to first dose (e.g., gastrointestinal bleeding, intracranial hemorrhage).
• Prior diagnosis of pulmonary embolism within 3 months prior to first dose.
• Known intolerance, hypersensitivity, or contraindication to any components of MDK-703 or checkpoint inhibitors for applicable cohorts.

Sponsors & Collaborators

• Medikine, Inc.: lead

Study Sites (6)

Sarah Cannon Research Institute (Florida Cancer Specialists)

Sarasota, Florida, 34232, United States

Location

Carolina BioOncology Institute

Huntersville, North Carolina, 28078, United States

Location

NEXT Oncology Austin

Austin, Texas, 78758, United States

Location

Mary Crowley Cancer Research

Dallas, Texas, 75251, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

NEXT Oncology Virginia

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis; Pancreatic Neoplasms; Prostatic Neoplasms; Breast Neoplasms; Ovarian Neoplasms

Interventions

Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Neoplasms, Female; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Joseph Leveque, MD

  Chief Medical Officer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multiple ascending dose escalation followed by dose expansion.

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: February 8, 2023
• Study Start: February 8, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)