This study has been transitioned to CTIS with ID 2023-503749-76-00 check the CTIS register for the current data. This entry-into-human (EIH) Phase Ia/Ib study aims to establish the safety,pharmacokinetics, immunogenicity, and pharmacodynamics of…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
metastatic solid tumors
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary objectives:
- To evaluate the safety and tolerability of RO7284755 alone (Part 1) or in
combination with atezolizumab (Part 2)
Endpoint: Incidence, nature, and severity of adverse events (AEs) graded
according to the National Cancer Institute (NCI) Common Terminology Criteria
for Adverse Events (CTCAE)
- To determine the maximum-tolerated dose (MTD) and/or the recommended dose for
extension (RDE) of RO7284755 (Part 1 and Part 2) Endpoint: Nature and frequency
of dose-limiting toxicities (DLTs)
- To evaluate the anti-tumor activity of study treatment (Part 3)
Endpoint: Objective response rate (ORR) according to RECIST v1.1
Secondary outcome
To evaluate the anti-tumor activity of study treatment (Part 1 and Part 2)
To evaluate the safety and tolerability of the study treatment (Part 3)
The precise secondary and Exploratory objectives and endpoints are stated in
section3, table 9 of the protocol.
Background summary
RO7284755, a PD-1 targeted IL-2 variant immunocytokine, is being developed for
the treatment of patients with advanced and/or metastatic solid tumors.
A detailed description of the background of disease, current therapies, unmet
medical needs as well as a description of chemistry, pharmacology, efficacy,
and safety of RO7284755 is provided in the Investigator*s Brochure.
Section 2 of the protocol extensively describes the background and rationale of
the study.
Study objective
This study has been transitioned to CTIS with ID 2023-503749-76-00 check the CTIS register for the current data.
This entry-into-human (EIH) Phase Ia/Ib study aims to establish the safety,
pharmacokinetics, immunogenicity, and pharmacodynamics of RO7284755 (alone or in
combination with atezolizumab) and to evaluate its anti-tumor activity.
Study design
This is an EIH, open-label, multicenter, randomized, Phase Ia/Ib, adaptive,
multiple ascending dose study of RO7284755 as single agent or in combination
with atezolizumab.
The study will enroll adult participants with solid tumors considered
responsive to checkpoint inhibition blockade, as described in Section 5.
The study consists of 3 parts: dose-escalation of RO7284755 as a single agent
(Part 1), dose-escalation of RO7284755 in combination with atezolizumab (Part
2), and extension of RO7284755 as a single agent and/or in combination with
atezolizumab (Part 3).
The treatment groups in the different parts of the study design are as follows:
Part 1: Dose-Escalation of RO7284755 as a Single Agent
Part 2: Dose-Escalation of RO7284755 in Combination with Atezolizumab
Part 3: Extension of RO7284755 as a Single Agent and/or in Combination with
Atezolizumab Prior to start
Intervention
For the purpose of the study, RO7284755 and atezolizumab are considered
investigational medicinal products (IMPs).
An overview of all treatments is given in Tables 1-4 and 7.
In Figures 1-3 of the protocol a schematic overview is given of the study
design.
Study burden and risks
RO7284755 is not given in humans before.
Risks and possible side affects are described in section 6 and in appendix D of
the ICF
Beneluxlaan 2a
Woerden 3446 GR
NL
Beneluxlaan 2a
Woerden 3446 GR
NL
Listed location countries
Age
Inclusion criteria
- Age >=18 years
- Locally advanced/unresectable or metastatic disease
- Measurable disease, as defined by Response Evaluation Criteria in Solid
Tumors version 1.1 (RECIST v1.1)
- Eastern Cooperative Oncology Group Performance Status 0 to 1
- Life expectancy of >= 12 weeks
- Consent to provide an archival tumor tissue sample
- Adequate cardiovascular, hematological, coagulative, hepatic and renal
function
- Female Participants: A female participant is eligible to participate if
she is not pregnant, not breastfeeding, woman of childbearing potential (WOCBP)
must agree to remain abstinent or use of two, highly effective contraceptive
methods that result in a failure rate of < 1% per year during the treatment
period and for at least 1 month after last dose of RO7284755 or at least 5
months after the last dose of atezolizumab whichever is longer
Exclusion criteria
- Rapid disease progression or suspected hyperprogression or threat to vital
organs or critical anatomical sites requiring urgent alternative medical
intervention
- Known active central nervous system (CNS) metastases
- History of treated asymptomatic CNS metastases
- Spinal cord compression not definitively treated with surgery and/or
radiation or previously diagnosed and treated spinal cord compression without
evidence that disease has been clinically stable for >= 2 weeks before Cycle1
Day 1 (C1D1)
- Active or history of carcinomatous meningitis/leptomeningeal disease
- Uncontrolled tumor-related pain or symptomatic hypercalcemia
- Concurrent second malignancy
- Evidence of significant, uncontrolled concomitant diseases that could
affect compliance with the protocol or interpretation of results
- Episode of significant cardiovascular/cerebrovascular acute disease within
28 days before study treatment administration
- Active or uncontrolled infections
- Known HIV infection
- Hepatitis B virus (HBV) or hepatitis C virus infection
- Adverse events related to any prior radiotherapy, chemotherapy, targeted
therapy, CPI therapy or surgical procedure must have resolved to Grade <=1,
except alopecia Grade 2 peripheral neuropathy, and hypothyroidism and/or
hypopituitarism on a stable dosage of hormone replacement therapy
- Participants with bilateral pleural effusion
- Major surgery or significant traumatic injury < 28 days before study
treatment administration or anticipation of the need for major surgery during
study treatment
- Known allergy or hypersensitivity to any component of the formulations of
the IMPs to be administered, including but not limited to hypersensitivity to
Chinese hamster ovary cell products or other recombinant or humanized antibodies
- History of severe allergic anaphylactic reactions to chimeric, human or
humanized antibodies, or fusion proteins
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2023-503749-76-00 |
| EudraCT | EUCTR2019-004022-25-NL |
| CCMO | NL72306.056.20 |