Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO7119929 · 1 trial · 4 indications
A DLT is defined as a clinically significant AE (classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] v.5.0) or significant laboratory abnormality 1) occurring during an assessment period of 21 days or 28 days after first dose of study treatment, respectively, and 2) is not attributed to disease progression, concomitant illness or another clearly identifiable cause.
An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
| Arm | Type | Description |
|---|---|---|
| Part A1-1 mg RO7119929 | EXPERIMENTAL | Participants received 1mg RO7119929 every week in 3-week cycles. |
| Part A1-3 mg RO7119929 | EXPERIMENTAL | Participants received 4 mg RO7119929 every week in 3-week cycles |
| Part A1 - 6 mg RO7119929 | EXPERIMENTAL | Participants received 6 mg RO7119929 every week in 3-week cycles |
| Part A1 -9 mg RO7119929 | EXPERIMENTAL | Participants received 9 mg RO7119929 every week in 3-week cycles |
| Part B1-5 mg RO7119929 | EXPERIMENTAL | Participants with both available and evaluable tumor biopsy samples received 5 mg RO7119929 on Cycle 1 Day 1 to month 12 |
| Part A2- 2/5/5 mg RO7119929 | EXPERIMENTAL | Participants received RO7119929 QW with step-up dosing of 2/5/5 mg during Cycle 1. |
| Part A2- 2/5/6 mg RO7119929 | EXPERIMENTAL | Participants received RO7119929 QW with step-up dosing of 2/5/6 mg during Cycle 1. |
| Part A3-4 mg RO7119929 | EXPERIMENTAL | Participants received tocilizumab pre-treatment on Cycle 1 Day 1, approximately 2 hours prior to RO7119929 administration and 4 mg RO7119929 every week in 3-week cycles |
| Name | Type | Description |
|---|---|---|
| RO7119929 | DRUG | RO7119929 will be administered orally as a capsule |
| Tocilizumab | DRUG | Tocilizumab will be administered in case of severe steroid-refractory cytokine release syndrome. Tocilizumab will be administered as concentrate for solution for IV infusion at a dose: for participants \> 30 kg: 8 mg/kg, for participants \< 30 kg: 12mg/kg IV |
Inclusion Criteria: * Histologically confirmed diagnosis of one of the following: unresectable advanced or metastatic HCC (including fibrolamellar HCC) not amenable to a curative treatment approach, unresectable advanced or metastatic intrahepatic or perihilar (Klatskin) BTC not amenable to a curat...
RO7119929 is an investigational small molecule being studied for the treatment of unresectable advanced or metastatic hepatocellular carcinoma, biliary tract cancer, or solid tumors with hepatic metastases. It is a TLR7 agonist designed for use in oncology, specifically targeting cancers that have spread to the liver.
RO7119929 targets TLR7, a toll-like receptor involved in immune activation. As a TLR7 agonist, it is intended to stimulate the immune system to recognize and attack cancer cells. This mechanism is being evaluated in patients with hepatocellular carcinoma and other liver-related cancers.
RO7119929 is being developed by Roche Holding AG, a multinational healthcare company. Roche is conducting clinical research on this investigational drug for the treatment of advanced liver cancers and solid tumors with hepatic metastases.
RO7119929 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is no longer in active clinical testing according to available trial records.
RO7119929 has been studied in one clinical trial, identified as NCT04338685. This Phase 1 study evaluated the safety, pharmacokinetics, pharmacodynamics, and clinical activity of RO7119929 in participants with unresectable advanced or metastatic hepatocellular carcinoma, biliary tract cancer, or solid tumors with hepatic metastases. The trial enrolled 55 participants and has been completed.
RO7119929 is a TLR7 agonist, meaning it activates the TLR7 receptor. This mechanism is central to its intended function in cancer treatment. The drug is being investigated for its ability to stimulate immune responses against tumors, particularly in liver cancers and metastases.