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

Part of paid clinical trials in Sacramento, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT04580121
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RO7283420 — DRUG
    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.
  • RO7283420 — DRUG
    RO7283420 at RP2D will be administered by IV infusion or SC injection as per dosing schedule determined in Part B.
  • Tocilizumab — DRUG
    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.
  • Dasatinib — DRUG
    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.
  • Dexamethasone — DRUG
    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.
  • Paracetamol/acetaminophen — DRUG
    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.
  • Diphenhydramine — DRUG
    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.

Study Details

This open-label, entry-into-human (EIH) study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of RO7283420. Escalating doses of RO7283420 will be administered to participants with Acute Myeloid Leukemia (AML) in order to determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D).

Key Dates

Start date
Nov 4, 2020
Status verified
May 2024
Primary completion
Aug 9, 2023
Completion
Aug 9, 2023

Study Design

Enrollment
59 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Single Participant Dose Escalation
    Participants from Group I will receive escalating doses of RO7283420, once every 3 weeks (Q3W) starting on Cycle 1, Day 1 (C1D1) for up to 6 cycles with a starting dose of 0.15mg.
  • Experimental: Part B: Multiple Participant Dose Escalation
    Multiple-participant cohorts of \>= 3 participants will be enrolled for dose escalation for Group I and Group II independently. Participants will be administered a starting dose of 0.15 mg or highest dose administered in Part A. Each participant will receive up to 6, 9, and 18 cycles of treatment with RO7283420, when treated with Q3W, every-2-weeks (Q2W), or once-a-week (QW) dosing regimens, respectively to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). Additionally, step-up dosing regimens with more frequent administrations of RO7283420 during cycle 1 will be evaluated.
  • Experimental: Part C: Dose Expansion
    Participants will receive the respective RP2D for Group I and Group II.

Primary Outcome Measure

Percentage of Participants with Adverse Events (AEs) [ Time Frame: From baseline up to 9 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
UC Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-4009-

Find similar trials in Sacramento, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
UC Davis Comprehensive Cancer Center· Sacramento, CAThe University of Texas MD Anderson Cancer Center· Houston, TX

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