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Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)

Study acronym: RAINFOL-01
StatusRecruiting
PhasePhase 1/2
SponsorGenmab
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoints added 4 → 6 primary endpoints
See other at-risk trials from Genmab

Record History

  1. Primary endpoint(s) modified Interventions modified · Trial arms changed: 4 → 5 · Enrollment target: 884 to 952 · 4 more Show 7 more changesShow less
    • Interventions modified
    • Trial arms changed: 4 → 5
    • Enrollment target: 884 to 952
    • Eligibility criteria expanded, about 188 words
    • Secondary endpoints: 14 to 15
    • Study description expanded, about 6 words
    • Site details revised at 11 of 66 sites
  2. 2 versions Re-verified since Jul 6, 2026, no change to tracked fieldsv38-v39
  3. Site details revised at 8 of 66 sitesv37
  4. Primary endpoint(s) modified Enrollment increased: 764 → 884 participants · Eligibility criteria expanded, about 15 words · Secondary endpoints: 13 to 14 · 1 morev36 Show 4 more changesShow less
    • Enrollment increased: 764 → 884 participants
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: 13 to 14
    • Study description expanded, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 67 to 66v35
Show 33 earlier versionsHide 33 earlier versions
  1. Site details revised at 9 of 67 sitesv34
  2. Study sites: 56 to 67v33
  3. Study sites: 52 to 56v32
  4. Primary endpoints revised (4) Enrollment target: 569 to 764 · Study sites: 38 to 52 · Primary completion date: Jun 2027 to Jul 2027 · 4 morev31 Show 7 more changesShow less
    • Enrollment target: 569 to 764
    • Study sites: 38 to 52
    • Primary completion date: Jun 2027 to Jul 2027
    • Completion date: Sep 2027 to Oct 2027
    • Eligibility criteria expanded, about 42 words
    • Secondary endpoints revised (13)
    • Study description expanded, about 12 words

    See this version in full on ClinicalTrials.gov ↗

  5. 2 versions Re-verified since Sep 1, 2025, no change to tracked fieldsv29-v30
  6. Primary endpoints: 3 to 4 Enrollment target: 529 to 569 · Study sites: 37 to 38 · Eligibility criteria expanded, about 59 words · 2 morev28 Show 5 more changesShow less
    • Enrollment target: 529 to 569
    • Study sites: 37 to 38
    • Eligibility criteria expanded, about 59 words
    • Secondary endpoints revised (13)
    • Study description expanded, about 19 words

    See this version in full on ClinicalTrials.gov ↗

  7. 3 versions Re-verified since May 5, 2025, no change to tracked fieldsv25-v27
  8. Primary completion date: Apr 2026 to Jun 2027 Primary endpoints: 4 to 3 · Enrollment target: 404 to 529 · Study sites: 40 to 37 · 5 morev24 Show 8 more changesShow less
    • Primary endpoints: 4 to 3
    • Enrollment target: 404 to 529
    • Study sites: 40 to 37
    • Completion date: Oct 2026 to Sep 2027
    • Eligibility criteria expanded, about 180 words
    • Secondary endpoints: 14 to 13
    • Study description expanded, about 11 words
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  9. Re-verified, no change to tracked fieldsv23
  10. Enrollment target: 354 to 404 Study sites: 32 to 40 · Primary completion date: Oct 2025 to Apr 2026 · Completion date: Apr 2026 to Oct 2026 · 5 morev22 Show 8 more changesShow less
    • Study sites: 32 to 40
    • Primary completion date: Oct 2025 to Apr 2026
    • Completion date: Apr 2026 to Oct 2026
    • Interventions: PRO1184 (Drug), PRO1184 intravenous infusion of PRO1184 (Drug), PRO1184 intravenous infusion of PRO1184 (Drug), PRO1184 intravenous… to Bevacizumab (Drug), Carboplatin (Drug), Pembrolizumab (Drug), Rina-S (Drug)
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoints revised (14)
    • Study description expanded, about 4 words
    • Study title expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  11. 3 versions Re-verified since Sep 2, 2024, no change to tracked fieldsv19-v21
  12. Lead sponsor: ProfoundBio US Co. to Genmabv18
  13. Primary endpoints revised (4) Enrollment target: 374 to 354 · Study sites: 22 to 32 · Eligibility criteria expanded, about 104 words · 2 morev17 Show 5 more changesShow less
    • Enrollment target: 374 to 354
    • Study sites: 22 to 32
    • Eligibility criteria expanded, about 104 words
    • Secondary endpoints: 11 to 14
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  14. Enrollment target: 134 to 374 Primary completion date: Jan 2025 to Oct 2025 · Primary endpoints: 2 to 4 · Study sites: 16 to 22 · 6 morev16 Show 9 more changesShow less
    • Primary completion date: Jan 2025 to Oct 2025
    • Primary endpoints: 2 to 4
    • Study sites: 16 to 22
    • Completion date: Sep 2025 to Apr 2026
    • Interventions: PRO1184 (Drug) to PRO1184 (Drug), PRO1184 intravenous infusion of PRO1184 (Drug), PRO1184 intravenous infusion of PRO1184 (Drug), PRO1184 intravenous…
    • Eligibility criteria expanded, about 188 words
    • Secondary endpoints: 8 to 11
    • Study description shortened, about 48 words
    • Study arms: 1 to 4

    See this version in full on ClinicalTrials.gov ↗

  15. Study sites: 17 to 16v15
  16. Site details revised at 1 of 17 sitesv14
  17. Site details revised at 1 of 17 sitesv13
  18. Study sites: 16 to 17v12
  19. Study sites: 11 to 16v11
  20. Site details revised at 1 of 11 sitesv10
  21. Study sites: 12 to 11v9
  22. Study sites: 10 to 12v8
  23. Start date changed from estimate of Nov 28, 2022 to Dec 7, 2022 Site details revised at 1 of 10 sitesv7 Show 1 more changeShow less
    • Site details revised at 1 of 10 sites
  24. Study sites: 9 to 10 Start date: Nov 2, 2022 to Nov 28, 2022v6 Show 1 more changeShow less
    • Start date: Nov 2, 2022 to Nov 28, 2022
  25. Re-verified, no change to tracked fieldsv5
  26. Study sites: 8 to 9v4
  27. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Nov 2022 to Nov 2, 2022 · Site details revised at 8 of 8 sitesv3 Show 2 more changesShow less
    • Start date changed from estimate of Nov 2022 to Nov 2, 2022
    • Site details revised at 8 of 8 sites
  28. Study sites: 0 to 8v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Genmab
45 trials monitored
See 3 trials at risk
Breast Cancer
5,213 trials monitored
See 271 trials at risk
Lung Cancer
4,057 trials monitored
See 217 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
2,932 trials monitored
See 157 trials at risk
and 5 more diseases
This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).
Trial Details
NCT Number NCT05579366
Lead Sponsor Genmab
Conditions High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer, Endometrial Cancer, Non-small Cell Lung Cancer, Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (NSCLC), Mesothelioma +8 more
Enrollment 952 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov