Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO7122290 · 1 trial · 1 indication
The DLT observation period is defined as a period of 21 days after the first administration of RO7122290 combined with cibisatamab. Additional days (maximum 3 days per dosing) are allowed in case of treatment delays for non-safety reasons. Participants are evaluable for DLT assessment, if they have received one dose of cibisatamab and at least two doses of RO7122290 during the DLT period.
Incidence, nature, and severity of adverse events (AEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5 with the exception of cytokine release syndrome (CRS), which is graded according to the ASTCT grading scale for CRS (with individual signs and symptoms of CRS graded separately using the CTCAE v5.0 grading scale)
| Arm | Type | Description |
|---|---|---|
| Part I: Dose-escalation of RO7122290 | EXPERIMENTAL | The dose-escalation of RO7122290 will use a QW dosing schedule of RO7122290 in combination with a Q3W dosing interval for cibisatamab with obinutuzumab pre-treatment. The starting dose for RO7122290 will be 35 mg, which represents the human equivalent dose for the minimal pharmacologically active dose (1 mg/kg) in mice. |
| Part II: Dose-expansion of RO7122290 | EXPERIMENTAL | Part II of this study will evaluate selected dose levels of RO7122290 from Part I (a QW RO712290 administration in combination with a Q3W cibisatamab administration with obinutuzumab pre-treatment) in a Q3W regimen in combination with a Q3W cibisatamab administration with obinutuzumab pre-treatment. |
| Name | Type | Description |
|---|---|---|
| RO7122290 | DRUG | RO7122290 will be administered using a QW (Part I) or Q3W (Part I or Part II) schedule in combination with 100 mg cibisatamab Q3W with obinutuzumab pre-treatment. The maximum dose of RO7122290 to be explored in combination with cibisatamab with obinutuzumab pre-treatment in this study is 500 mg for the QW dosing interval (Part I) or 1500 mg for the Q3W dosing interval (Part I or Part II). |
| Cibisatamab | DRUG | Cibisatamab will be administered to participants at a fixed dose of 100 mg Q3W (100 mg on Day 1 of each 21-day cycle). |
| Obinutuzumab | DRUG | Obinutuzumab will be administered (IV) as pre-treatment on Day - 8/- 7 (split dose) or \- 8 (single dose) prior to C1D1 of cibisatamab and as re-treatment every 6 months if the participant is still receiving cibisatamab |
Inclusion Criteria: * Histologically confirmed adenocarcinoma originating from the colon or rectum. * Metastatic disease (Stage IV American Joint Committee on Cancer, Version 7) not amenable to local treatment. * Tumors that are MSS (microsatellite-stable) or MSI-low (microsatellite instable low), ...
Top 20 of 77 competitors
RO7122290 is an investigational small molecule being studied for the treatment of metastatic colorectal cancer. It is in Phase 1 clinical development and has been evaluated in a completed clinical trial in combination with cibisatamab and obinutuzumab pre-treatment.
RO7122290 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The drug is currently in Phase 1 clinical development for metastatic colorectal cancer.
RO7122290 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed.
RO7122290 has been studied in one completed Phase 1 clinical trial, NCT04826003. This trial evaluated the safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of RO7122290 in combination with cibisatamab, with obinutuzumab pre-treatment, in patients with metastatic colorectal cancer.
No, RO7122290 is not the same as cibisatamab. RO7122290 is the investigational drug being studied, while cibisatamab is a separate agent used in combination with RO7122290 in the clinical trial. The trial also included obinutuzumab as a pre-treatment.