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Endometrial CancerPhase 1/2NCT06171789

PRO1107 in Patients With Advanced Solid Tumors

A Phase 1/2 study testing GEN1107 in people with Endometrial Cancer and Ovarian Cancer, run by Genmab at 7 sites in 2 countries.

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 a global, open-label, multicenter Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of GEN1107 (PRO1107) in participants with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
GEN1107
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
7 sitesin 2 countries
Study dates
3 Jan 2024to 18 Aug 2025
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Part A:
  • Pathologically confirmed diagnosis of one of the following tumor types:
  • Ovarian cancer (epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer)
  • Endometrial cancer (any subtype excluding sarcoma)
  • Triple negative breast cancer (TNBC)
  • Non-small cell lung cancer (NSCLC)
Show all 14Show fewer
  • Metastatic or unresectable locally advanced, recurrent, disease not amenable to further local therapy following prior systemic therapies known to confer clinical benefit.
  • Part B:
  • Participants must have a histologically or cytologically confirmed metastatic or unresectable solid malignancy as specified below:
  • Ovarian cancer
  • TNBC
  • Endometrial cancer
  • NSCLC
  • Measurable disease at baseline as defined per RECIST, Version 1.1

Who cannot join

  • Prior treatment with anti-PTK7-directed therapy.
  • Had progressive disease as best response while on treatment with an auristatin (eg, a vedotin or pelidotin)- based ADC as the most recent line of therapy.
  • History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (eg, 5-year overall survival [OS] ≥90%)
  • Known active central nervous system metastases, including carcinomatous meningitis. Participants with brain metastases may participate provided the metastases have been treated and are stable for at least 4 weeks prior to the first dose of study drug, they have no new or enlarging brain metastases and have discontinued corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug. Participants with a history of brain metastases, suspected new brain metastases, or a diagnosis of NSCLC or breast cancer should have a computed tomography (CT)/ magnetic resonance imaging (MRI) scan of the brain at screening.
  • Participants with active or chronic corneal disorders, history of corneal transplantation, or any clinically significant corneal disease that prevents adequate monitoring of potential drug-induced keratopathy. Note: Participants with other active ocular conditions requiring ongoing therapy and/or monitoring must be discussed with the sponsor prior to enrollment.
  • Additional protocol defined inclusion/exclusion criteria may apply.

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

United States6 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

  • START Mountain Cancer Center

    Salt Lake City, Utah, 78229

  • Florida Cancer Specialists

    Sarasota, Florida, 34236

  • HonorHealth Research Institute

    Scottsdale, Arizona, 85258

Other trials in United States

China1 site

  • Institution of Hunan Cancer Hospital

    Changsha, Hunan, 410013

Other trials in China

About this study

Official title: A Phase 1/2 Study of PRO1107 in Patients With Advanced Solid Tumors

This is a global, open-label, multicenter Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of GEN1107 (PRO1107) in participants with advanced solid tumors. This study consists of 2 parts, Part A: dose escalation and dose level expansion, and Part B: tumor specific expansion.

Read the detailed description

This is a Phase 1/2 study of GEN1107, a protein tyrosine K 7 (PTK7) targeted antibody-drug conjugate (ADC), to evaluate the safety, tolerability, PK, and antitumor activity of GEN1107 in participants with advanced solid tumors, including ovarian cancer, endometrial cancer, triple negative breast cancer, non-small cell lung cancer, gastroesophageal cancer, and urothelial cancer. This study consists of 2 parts, Part A: Dose Escalation and Dose Level Expansion and Part B: Tumor Specific Expansion.

In Part A, GEN1107 will be administered in different dosing regimens via intravenous (IV) infusion.

Part B will be initiated at a dose level based on a comprehensive analysis of safety, tolerability, clinical PK, pharmacodynamics (PD) and activity data from Part A in up to 4 different tumor-specific cohorts of up to 40 participants per cohort.

Participants will continue to receive study treatment until the first instance of disease progression, unacceptable toxicity, investigator decision, consent withdrawal, study termination by the Sponsor, pregnancy, or death.

Being tested
GEN1107
Medical subject headings
Endometrial Neoplasms, Ovarian Neoplasms, Triple Negative Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Transitional Cell

What participants receive

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

  • GEN1107Drug

    IV infusion of GEN1107

Study groups in NCT06171789
Study groupRoleWhat they receive
GEN1107ExperimentalGEN1107 monotherapy in escalating doses in Part A and at the dose level in Part B.
Receives: Drug: GEN1107

What is being measured

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

  1. Number of Participants with Adverse Events

    Type, incidence, severity, seriousness, and relatedness of adverse events.

    Measured: Through end of treatment, up to approximately 1 year

  2. Number of Participants with Dose Limiting Toxicities (DLTs)

    Incidence of dose limiting toxicities.

    Measured: Day 1 up to a maximum of Day 28

Secondary outcomes (10)

  1. Objective Response Rate

    Participants who achieve partial or complete response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.

    Measured: Through end of treatment, up to approximately 1 year

  2. Disease Control Rate

    Participants who achieve stable disease, partial or complete response per RECIST v1.1 criteria.

    Measured: Through end of treatment, up to approximately 1 year

  3. Progression-free Survival

    Time from start of treatment to first documented disease progression or death.

    Measured: Up to approximately 18 months

  4. Duration of Objective Response

    Time from the first documentation of an objective tumor response (complete response or partial response) to the first documented tumor progression or death.

    Measured: From date of enrollment until the date of first documented disease progression or date of study withdrawal, whichever came first, assessed up to 12 months

  5. Pharmacokinetic Parameter Area Under the Curve (AUC) for GEN1107

    Measure of GEN1107 AUC in plasma.

    Measured: Varying timepoints through end of treatment, up to approximately 1 year

  6. Pharmacokinetic Parameter Maximum Concentration (Cmax) for GEN1107

    Measure of the Cmax of GEN1107 in plasma.

    Measured: Varying timepoints through end of treatment, up to approximately 1 year

  7. Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) for GEN1107

    Measure of the Tmax of GEN1107 in plasma.

    Measured: Varying timepoints through end of treatment, up to approximately 1 year

  8. Pharmacokinetic Parameter Apparent Terminal Half-life (t1/2) for GEN1107

    Measure of t1/2 of GEN1107 in plasma.

    Measured: Varying timepoints through end of treatment, up to approximately 1 year

  9. Pharmacokinetic Parameter Trough Concentration (Ctrough) for GEN1107

    Measure of the Ctrough of GEN1107 in plasma.

    Measured: Varying timepoints through end of treatment, up to approximately 1 year

  10. Cancer Antigen 125 (CA-125) Response per Gynecological Cancer Intergroup (GCIG) Criteria for Ovarian Cancer

    Measured: Varying timepoints through end of treatment, up to approximately 1 year

Timeline

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

  1. First posted15 Dec 2023
  2. Study start3 Jan 2024
  3. Primary completion18 Aug 2025
  4. Study completion18 Aug 2025

Why it stopped: Genmab has decided to discontinue the clinical development of GEN1107 as the overall benefit-risk profile no longer supports continuation

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
Not applicable
Intervention model
Single group
Model description
Modified toxicity probability interval (mTPI)
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06171789
Sponsor's protocol ID
GCT1107-01
Other IDs
CTR20242075, PRO1107-01
Status last verified
Feb 2026
First submitted
29 Nov 2023
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
No
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 GEN1107 in people with Endometrial Cancer and Ovarian Cancer, run by Genmab at 7 sites in 2 countries.

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 14 inclusion and 6 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 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, China. 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: Genmab has decided to discontinue the clinical development of GEN1107 as the overall benefit-risk profile no longer supports continuation). 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?

Number of Participants with Adverse Events (time frame: Through end of treatment, up to approximately 1 year). The study lists 2 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 NCT06171789.

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 1 Jun 2026.

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