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NCT06171789

PRO1107 in Patients With Advanced Solid Tumors

StatusTerminated
PhasePhase 1/2
SponsorGenmab
Primary completion
Track this trial

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Record History

All 19 versions: 12 with changes below, 7 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Results posted: Oct 29, 2026
    • Primary endpoints revised (2)
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints revised (10)
  2. Secondary endpoints: 11 to 10v18
  3. Start date: Jan 29, 2024 to Jan 3, 2024v17
  4. Trial status: Active, Not Recruiting to Terminated Sponsor's reason: Genmab has decided to discontinue the clinical development of GEN1107 as the overall benefit-risk profile no longer supports continuation
    • Study sites: 6 to 7
    • Primary and study completion dates changed from estimate of Jun 2028 to Aug 18, 2025
    v16
  5. Enrollment target: 42 to 33v15
Show 6 earlier versionsHide 6 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 280 to confirmed 42
    • Site details revised at 6 of 6 sites
    v14
  2. Primary and study completion dates: Feb 2027 to Jun 2028v10 Show 7 more changesShow less
    • Primary endpoints: 3 to 2
    • Enrollment target: 214 to 280
    • Study sites: 4 to 6
    • Interventions: PRO1107 (Drug) to GEN1107 (Drug)
    • Eligibility criteria expanded, about 142 words
    • Secondary endpoints: 9 to 11
    • Study description expanded, about 5 words
  3. Lead sponsor: ProfoundBio US Co. to Genmabv5
  4. Study sites: 2 to 4v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Jan 2024 to Jan 29, 2024
    v3
  6. Eligibility criteria shortened, about 3 wordsv2
  1. Study First Submitted
  • Stopped: terminated, suspended or withdrawn
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to approximately 1 year, 7 months
Number of Participants With Dose Limiting Toxicities (DLTs)
Timeframe: Up to 28 days

Secondary (10)

Objective Response Rate (ORR)
Disease Control Rate (DCR)
Progression-free Survival (PFS)
Duration of Objective Response (DOR)
Area Under the Curve (AUC) of GEN1107 Related Analytes
Show 5 moreShow less
Maximum Concentration (Cmax) of GEN1107 Related Analytes
Time to Maximum Concentration (Tmax) of GEN1107 Related Analytes
Apparent Terminal Half-life (t1/2) of GEN1107 Related Analytes
Trough Concentration (Ctrough) of GEN1107 Related Analytes
Number of Participants With Cancer Antigen 125 (CA-125) Response Per Gynecological Cancer Intergroup (GCIG) Criteria for Ovarian Cancer

Arms and interventions

GEN1107Experimental

GEN1107 monotherapy in escalating doses in Part A and at the dose level in Part B.

Drugs: GEN1107

Sites

7 sites in 2 countries

United States 6, China 1