Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Digestive System Diseases

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Breast Neoplasms

Prostatic Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Pancreatic Neoplasms

Respiratory Tract Infections

Ovarian Cancer

Ovarian Epithelial Cancer

Pancreatic Cancer

All Drugs and Chemicals

Antineoplastic Agents

Immunomodulating Agents

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

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

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

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

MDK-703

Checkpoint inhibitor will be administered as specified under Arm description.

Checkpoint Inhibitor, Immune

Joseph Leveque, MD

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.

This is a Phase 1/2, open-label, multicenter, dose escalation and dose expansion study evaluating MDK-703 in adult study participants with advanced or metastatic solid tumors. This study will initially commence with dose escalation to evaluate the safety/tolerability of MDK-703 as a monotherapy and in combination with other cancer therapies. Once the monotherapy and/or combination therapy maximum tolerated dose (MTD), optimal biological dose (OBD), and/or recommended dose (RD) has been determined, then dose expansion of MDK-703 may commence in select populations of interest. The study will also evaluate the anti-tumor activity and pharmacokinetic (PK) and pharmacodynamic (PD) profiles of MDK-703 as a monotherapy and in combination with other cancer therapies.

Multiple ascending dose escalation followed by dose expansion.

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

A Phase 1/2, Open-Label, Multicenter Study of MDK-703 as a Monotherapy and in Combination With Other Anti-Cancer Therapies in Patients With Advanced or Metastatic Solid Tumors (ORCHID-1)

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

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

Based on assessment of radiographic imaging per RECIST version 1.1

Blood concentration of MDK-703 at various timepoints

Time to achieve maximum blood concentration of MDK-703

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Dose Escalation/Expansion Study of MDK-703 in Patients With Advanced or Metastatic Solid Tumors	NCT05716295	Advanced or Met...	MDK-703 Checkpoint Inhi...	18 Years - 99 Years	Medikine, Inc.
A Dose Escalation/Expansion Study of MDK-703 in Patients With Advanced or Metastatic Solid Tumors	NCT05716295	Advanced or Met...	MDK-703 Checkpoint Inhi...	18 Years - 99 Years	Medikine, Inc.

Spots Global Cancer Trial Database for microsatellite stable crc