Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-29 @ 4:29 PM
Study NCT ID:
NCT04557150
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-26
First Post:
2020-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Forimtamig in Participants With Relapsed or Refractory Multiple Myeloma (r/r MM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 225}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-02-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2020-09-17', 'studyFirstSubmitQcDate': '2020-09-17', 'lastUpdatePostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants with Adverse Events (AEs)', 'timeFrame': 'Up to 104 weeks'}, {'measure': 'Percentage of Participants with Dose Limiting Toxicities (DLTs)', 'timeFrame': 'Cycle 1 Day 1 up to Cycle 1 Day 35'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to 104 weeks'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to 104 weeks'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Up to 104 weeks'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 104 weeks'}, {'measure': 'Percentage of Participants with Anti-Drug Antibodies (ADAs) to Forimtamig', 'timeFrame': 'Up to 104 weeks'}, {'measure': 'Maximum Concentration (Cmax) of Forimtamig', 'timeFrame': 'Up to 104 weeks'}, {'measure': 'Time of Maximum Concentration (Tmax) of Forimtamig', 'timeFrame': 'Up to 104 weeks'}, {'measure': 'Minimum Concentration (Cmin) of Forimtamig', 'timeFrame': 'Up to 104 weeks'}, {'measure': 'SC Bioavailability (F) of Forimtamig', 'timeFrame': 'Up to 104 weeks'}, {'measure': 'Apparent Clearance (CL/F) of Forimtamig', 'timeFrame': 'Up to 104 weeks'}, {'measure': 'Volume of Distribution at Steady State (Vss) of Forimtamig (IV only)', 'timeFrame': 'Up to 104 weeks'}, {'measure': 'Area Under the Curve (AUC) at Various Time Intervals of Forimtamig', 'timeFrame': 'Up to 104 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '39476124', 'type': 'DERIVED', 'citation': 'Eckmann J, Fauti T, Biehl M, Zabaleta A, Blanco L, Lelios I, Gottwald S, Rae R, Lechner S, Bayer C, Dekempe Q, Osl F, Carrie N, Kassem S, Lorenz S, Christopeit T, Carpy A, Bujotzek A, Broske AM, Dekhtiarenko I, Attig J, Kunz L, Cremasco F, Adelfio R, Fertig G, Dengl S, Gassner C, Bormann F, Kirstenpfad C, Kraft T, Diggelmann S, Knobloch M, Hage C, Feddersen R, Heidkamp G, Poschinger T, Mayoux M, Bernasconi L, Prosper F, Dumontet C, Martinet L, Leclair S, Xu W, Paiva B, Klein C, Umana P. Forimtamig, a novel GPRC5D-targeting T-cell bispecific antibody with a 2+1 format, for the treatment of multiple myeloma. Blood. 2025 Jan 9;145(2):202-219. doi: 10.1182/blood.2024025987.'}]}, 'descriptionModule': {'briefSummary': 'This is a first-in-human, open-label, uncontrolled, multi-center, monotherapy, dose-escalation and dose expansion study. Forimtamig will be administered to participants with r/r MM for whom no standard-of-care treatment exists or who are intolerant to those established therapies. The study consists of two parts: dose-escalation of forimtamig (Part 1) and a randomized dose expansion of forimtamig (Part 2).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Previously diagnosed with Multiple Myeloma (MM) based on standard criteria.\n* Dose Escalation Phase and Dose Expansion Phase: Participants with r/r MM who have previously received therapy with an Immunomodulatory drug (IMiD) and Proteasome Inhibitor (PI) and are intolerant to or have no other option for standard-of-care treatment according to the Investigator.\n* Life expectancy of at least 12 weeks.\n* Agreement to provide protocol-specific biopsy material.\n* AEs from prior anti-cancer therapy resolved to Grade =\\<1.\n* Measurable disease.\n* For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating eggs.\n* For male participants: agreement to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating sperm.\n\nExclusion Criteria:\n\n* Inability to comply with protocol-mandated hospitalization and activities restrictions.\n* Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after last dose of study drug.\n* Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate for MM treatment within 2 weeks before first forimtamig administration.\n* Prior treatment with systemic immunotherapeutic agents within 2 weeks before first forimtamig administration.\n* Treatment-related, immune-mediated AEs associated with prior immunotherapeutic agents.\n* Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 2 weeks, prior to first forimtamig administration. Limited field palliative radiotherapy for bone pain or for soft tissue lesions is allowed.\n* Autologous or allogeneic stem cell transplantation (SCT) within 100 days prior to first forimtamig infusion and/or signs of chronic graft versus host disease or ongoing immunosuppressive medication.\n* Prior solid organ transplantation.\n* Active auto-immune disease or flare within 6 months prior to start of study treatment\n* Any medical condition or abnormality in clinical laboratory tests that, in the Investigator's or Medical Monitor's judgment, precludes the participant's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results."}, 'identificationModule': {'nctId': 'NCT04557150', 'briefTitle': 'A Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Forimtamig in Participants With Relapsed or Refractory Multiple Myeloma (r/r MM)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'An Open-Label, Multicenter, Phase I Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Forimtamig (RO7425781) in Participants With Relapsed or Refractory Multiple Myeloma', 'orgStudyIdInfo': {'id': 'BP42233'}, 'secondaryIdInfos': [{'id': '2020-002012-46', 'type': 'EUDRACT_NUMBER'}, {'id': '2023-504571-25-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part I: Dose Escalation', 'description': 'Participants will receive forimtamig as intravenous (IV) infusion and/or subcutaneous (SC) injection in a step-up dosing fashion.', 'interventionNames': ['Drug: Forimtamig']}, {'type': 'EXPERIMENTAL', 'label': 'Part II: Dose Expansion', 'description': 'Dose Expansion cohorts with IV and/or SC administration, respectively, will be initiated at the Recommended Phase 2 Doses (RP2Ds) determined in Part I: Dose Escalation phase.', 'interventionNames': ['Drug: Forimtamig']}], 'interventions': [{'name': 'Forimtamig', 'type': 'DRUG', 'otherNames': ['RO7425781'], 'description': 'Forimtamig will be administered via IV/SC administration. The RP2Ds determined during Part I: Dose Escalation will be administered during Part II: Dose Expansion. Forimtamig will be administered as per the dosing schedule defined in Part I.', 'armGroupLabels': ['Part I: Dose Escalation', 'Part II: Dose Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Center', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'UZ Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '2100', 'city': 'København Ø', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.70968, 'lon': 12.56862}}, {'zip': '5000', 'city': 'Odense C', 'country': 'Denmark', 'facility': 'Odense Universitetshospital', 'geoPoint': {'lat': 55.40841, 'lon': 10.39538}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'CHRU Lille - Hôpital Claude Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU NANTES - Hôtel Dieu', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '33604', 'city': 'Pessac', 'country': 'France', 'facility': 'Hopital De Haut Leveque', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '80131', 'city': 'Napoli', 'state': 'Campania', 'country': 'Italy', 'facility': 'IRCCS Istituto Nazionale dei Tumori di Napoli - Pascale Ematologia Oncologica', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '40138', 'city': 'Bologna', 'state': 'Emilia-Romagna', 'country': 'Italy', 'facility': 'Policlinico S.Orsola-Malpighi', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '20133', 'city': 'Milan', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'Fond. IRCCS Istituto Nazionale Tumori', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20089', 'city': 'Rozzano', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'Instituto Clinico Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'zip': '1010', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'New Zealand Clinical Research - Auckland', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06351', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06591', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Seoul St Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '39008', 'city': 'Santander', 'state': 'Cantabria', 'country': 'Spain', 'facility': 'Hospital Universitario Marques de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'facility': 'Clinica Universitaria de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '37007', 'city': 'Salamanca', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario de Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'St James University Hospital', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'W1T 7HA', 'city': 'London', 'country': 'United Kingdom', 'facility': 'University College London Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\\_sharing"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}