A Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7283420.

PHASE1CompletedINTERVENTIONAL
Enrollment

59

Participants

Timeline

Start Date

November 4, 2020

Primary Completion Date

August 9, 2023

Study Completion Date

August 9, 2023

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

RO7283420

RO7283420 will be administered to participants by intravenous (IV) infusion Q3W at a starting dose of 0.15mg. Starting dose levels (double step-up regimen, Q3W) for SC injections was the same as the highest dose levels that have been cleared in the IV double step-up cohorts at that timepoint. Each participant will receive up to 6, 9, and 18 cycles of treatment with RO7283420, when treated with Q3W, Q2W, or QW dosing regimens, respectively.

DRUG

RO7283420

RO7283420 at RP2D will be administered by IV infusion or SC injection as per dosing schedule determined in Part B.

DRUG

Tocilizumab

Tocilizumab will be administered as an IV infusion 8 mg/kg (for participants with a weight of 30 kg and above) and 12 mg/kg (for participants with a weight of less than 30 kg). Tocilizumab will be given as rescue medication.

DRUG

Dasatinib

Dasatinib 100 mg film-coated tablets will be administered daily until symptom resolution (up to 100 mg twice daily \[BID\] for a maximum 3 days); orally. Dasatinib will be given as rescue medication.

DRUG

Dexamethasone

20 mg IV of dexamethasone will be administered as pre-medication at least 60 minutes prior to the all RO7283420 infusions or injections during cycle 1.

DRUG

Paracetamol/acetaminophen

500 or 1000 mg of paracetamol/acetaminophen will be administered orally or by IV as pre-medication at least 30 minutes prior to each RO7283420 infusion or injection.

DRUG

Diphenhydramine

25 mg or 50 mg of diphenhydramine will be administered orally or by IV as pre-medication at least 30 minutes prior to each RO7283420 infusion or injection.

Trial Locations (23)

100

National Taiwan Universtiy Hospital; Division of Hematology, Taipei

404

China Medical University Hospital; Oncology and Hematology, Taichung

2100

Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT, København Ø

3000

Peter MacCallum Cancer Centre; Medical Oncology, Melbourne

3124

The Alfred, Melbourne

13273

Institut Paoli Calmettes; Departement D' Onco-Hematologie, Marseille

20089

Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia, Rozzano

24127

ASST PAPA GIOVANNI XXIII; Ematologia, Bergamo

28041

Hospital Univ. 12 de Octubre; Servicio de Hematologia, Madrid

33604

Hopital De Haut Leveque; Hematologie Clinique, Pessac

46026

Hospital Universitario la Fe; Servicio de Hematologia, Valencia

56100

Ospedale Santa Chiara; Unita Operativa Di Ematologia, Pisa

81377

Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III, München

95817

UC Davis Comprehensive Cancer Center, Sacramento

77030-4009

The University of Texas MD Anderson Cancer Center, Houston

M5G 1Z5

Princess Margaret Cancer Center, Toronto

01307

"Uniklinikum Carl Gustav Carus; Med. Klinik 1; Hämatologie, Zelltherapie und Medizinische Onkologie", Dresden

08916

Institut Catala d?Oncologia Hospital Germans Trias i Pujol, Badalona

08035

Hospital Universitari Vall d'Hebron; Servicio de Hematologia, Barcelona

08036

Hospital Clínic i Provincial; Servicio de Hematología y Oncología, Barcelona

00704

National Cheng Kung University Hospital; Oncology, Tainan City

OX3 7LJ

Churchill Hospital, Oxford

SM2 5PT

Royal Marsden NHS Foundation Trust, Sutton

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT04580121 - A Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7283420. | Biotech Hunter | Biotech Hunter