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

ConditionsHigh Grade Epithelial Ovarian CancerHigh Grade Serous Ovarian CancerPrimary Peritoneal CarcinomaFallopian Tube CancerEndometrial CancerNon-small Cell Lung CancerEpidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (NSCLC)MesotheliomaBreast AdenocarcinomaTriple Negative Breast CancerHormone Receptor-positive/Her2 Negative Breast CancerPlatinum-resistant Ovarian Cancer (PROC)Platinum Sensitive Ovarian Cancer (PSOC)Primary Refractory Ovarian CancerUterine CancerCervical Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenmab

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically or cytologically confirmed metastatic or unresectable solid malignancy including ovarian cancer (must have epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer), endometrial cancer, non-small cell lung cancer (Part A), EGFR-mutated NSCLC (Part B), breast cancer (hormone receptor positive, HER2-negative and triple-negative) (Part A), mesothelioma or cervical cancer (Part B).

Previously received therapies known to confer clinical benefit.

Measurable disease per RECIST v1.1 for all tumor types other than pleural mesothelioma which will use mRECIST v1.1 at baseline.

High grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (excluding endometrioid, clear cell carcinomas, mucinous, low grade, and those with a sarcomatous or neuroendocrine element)

Disqualifiers

History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids within the past 2 years, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.

Prior therapy with a topoisomerase 1 inhibitor-based antibody drug conjugate.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Rina-S

    Drug

    Intravenous infusion of Rina-S

  • Carboplatin

    Drug

    Carboplatin intravenous infusion

  • Bevacizumab

    Drug

    Bevacizumab intravenous infusion

  • Pembrolizumab

    Drug

    Pembrolizumab intravenous infusion

  • Erythromycin

    Drug

    Erythromycin oral administration

  • Itraconazole

    Drug

    Itraconazole oral administration

Treatment groups

952 Participants
are divided into 5 treatment groups
Group A: Part A, B, C, E, F, G, H, I, J and KExperimental treatment 1 intervention
Group B: Part D1Experimental treatment 2 interventions
Group C: Part D2 and IExperimental treatment 2 interventions
Group D: Part D3, D4 and D5Experimental treatment 2 interventions
Group E: Part LExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Parts A, B, and D - Incidence of Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]

Time frame
Through end of treatment, up to approximately 1 year.
2

Parts A, and D - Number of Participants with Dose Limiting Toxicity (DLT)

Time frame
At the end of Cycle 1 (each cycle is 21 days)
3

Parts C, E, F, G, H, I, and J- Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR, Parts C and F) or Investigator (Part E, G, I, and J) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Participants who achieve partial response (PR) or complete response (CR) per RECIST v1.1 criteria.

Time frame
Through end of treatment, up to approximately 1 year.
4

Part K (US Participants Only) - Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Findings by Holter

Time frame
Cycles 1 to 3 (each cycle is 21 days)

Secondary outcomes

1

Parts A, B, and D - Best Overall Response (BOR)

Participants who achieve CR or PR. Best response as assessed by the investigator per RECIST v1.1 criteria for all tumor types other than pleural mesothelioma which will use modified RECIST (mRECIST) v1.1.

Time frame
Up to approximately 1 year.
2

Parts A, B, D, and E - ORR

Participants who achieve PR or CR per RECIST v1.1 criteria.

Time frame
Up to approximately 1 year.
3

Parts A, B, and D - Disease Control Rate (DCR)

Participants who achieve stable disease, PR or CR per RECIST v1.1 criteria.

Time frame
Up to approximately 1 year.
4

Parts A, B, C, D, E, F, G, H, I, and J - Progression-Free Survival (PFS)

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

Time frame
Through end of treatment, up to approximately 1 year.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Genmab

Lead sponsor

Source ClinicalTrials.gov
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