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Advanced or Metastatic Solid TumorsPhase 1/2ORCHID-1NCT05716295

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

A Phase 1/2 study testing MDK-703 and Checkpoint Inhibitor, Immune in people with Advanced or Metastatic Solid Tumors, run by Medikine, Inc. at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Advanced or Metastatic Solid Tumors
What is being tested?
MDK-703 and Checkpoint Inhibitor, Immune
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
6 sitesUnited States
Study dates
8 Feb 2023to 30 Apr 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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.
  • History of other malignancy within 5 years prior to first dose, except for patients who are disease-free for >2 years after treatment with curative intent or who have carcinoma in situ which has been excised.
  • Any serious medical condition (including pre-existing autoimmune disease or inflammatory disorder), laboratory abnormality, psychiatric condition, or any other significant or unstable concurrent medical illness that in the opinion of the Investigator would preclude protocol therapy or would make the subject inappropriate for the study.
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • NEXT Oncology Austin

    Austin, Texas, 78758

  • Mary Crowley Cancer Research

    Dallas, Texas, 75251

  • NEXT Oncology Virginia

    Fairfax, Virginia, 22031

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Carolina BioOncology Institute

    Huntersville, North Carolina, 28078

  • Sarah Cannon Research Institute (Florida Cancer Specialists)

    Sarasota, Florida, 34232

Other trials in United States

About this study

Official title: 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)

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.

Read the detailed description

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.

Being tested
MDK-703, Checkpoint Inhibitor, Immune
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
Medical subject headings
Neoplasms, Neoplasm Metastasis, Pancreatic Neoplasms, Prostatic Neoplasms, Breast Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MDK-703Drug

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

  • Checkpoint Inhibitor, ImmuneDrug

    Checkpoint inhibitor will be administered as specified under Arm description.

Study groups in NCT05716295
Study groupRoleWhat they receive
MDK-703 MonotherapyExperimentalMDK-703 will be administered in sequential ascending doses as a monotherapy until unacceptable toxicity, disease progression, or withdrawal of consent.
Receives: Drug: MDK-703
MDK-703 in combination with a checkpoint inhibitorExperimentalMDK-703 will be administered in sequential ascending doses in combination with a checkpoint inhibitor until unacceptable toxicity, disease progression, or withdrawal of consent.
Receives: Drug: MDK-703; Drug: Checkpoint Inhibitor, Immune

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Limiting Toxicities (DLT)

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

    Measured: Assessed up to 24 months

  2. Maximum tolerated dose (MTD)

    Based on toxicities observed

    Measured: Assessed up to 24 months

  3. Optimal biological dose (OBD)

    Based on toxicities observed

    Measured: Assessed up to 24 months

  4. Recommended dose (RD)

    Based on toxicities observed

    Measured: Assessed up to 24 months

  5. Adverse events (AE)

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

    Measured: Assessed up to 24 months

Secondary outcomes (8)

  1. Objective Response Rate (ORR)

    Based on assessment of radiographic imaging per RECIST version 1.1

    Measured: Assessed up to 24 months

  2. Duration of Response (DOR)

    Based on assessment of radiographic imaging per RECIST version 1.1

    Measured: Assessed up to 24 months

  3. Time to Response (TTR)

    Based on assessment of radiographic imaging per RECIST version 1.1

    Measured: Assessed up to 24 months

  4. Disease Control Rate (DCR)

    Based on assessment of radiographic imaging per RECIST version 1.1

    Measured: Assessed up to 24 months

  5. Progression-Free Survival (PFS)

    Based on assessment of radiographic imaging per RECIST version 1.1

    Measured: Assessed up to 24 months

  6. Overall Survival (OS)

    Based on assessment of radiographic imaging per RECIST version 1.1

    Measured: Assessed up to 24 months

  7. Blood concentration of MDK-703

    Blood concentration of MDK-703 at various timepoints

    Measured: Assessed up to 24 months

  8. Time to achieve maximum blood concentration

    Time to achieve maximum blood concentration of MDK-703

    Measured: Assessed up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2023
  2. Study start8 Feb 2023
  3. Primary completion30 Apr 2024
  4. Study completion30 Apr 2024

Why it stopped: Corporate decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Multiple ascending dose escalation followed by dose expansion.
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05716295
Sponsor's protocol ID
MDK-703-102
Acronym
ORCHID-1
Status last verified
May 2024
First submitted
19 Jan 2023
Last updated
8 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MDK-703 and Checkpoint Inhibitor, Immune in people with Advanced or Metastatic Solid Tumors, run by Medikine, Inc. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Corporate decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicities (DLT) (time frame: Assessed up to 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05716295.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.

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