Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DNIB0600A · 2 trials · 2 indications
An AE is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of causality.
| Arm | Type | Description |
|---|---|---|
| Dose Escalation Cohort: DNIB0600A+Carboplatin | EXPERIMENTAL | DNIB0600A at an initial dose of 1.2 milligrams per kilogram (mg/kg) will be administered via intravenous (IV) infusion further following a dose-escalation until DLT under consultation of the investigator in combination with Carboplatin fixed dose of area under the curve (AUC)=6 mg/milliliter(mL)\*minute (min) administered by IV infusion on Day 1 of a 21-day cycle. |
| NSCLC Dose Expansion Cohort: DNIB0600A+Carboplatin | EXPERIMENTAL | Recommended phase 2 dose (RP2D) of DNIB0600A administered via IV infusion in combination with Carboplatin, AUC=6 mg/mL\*min administered via IV infusion on Day 1 of each 21-day cycle in participants with NSCLC until disease progression or death, whichever occurs first. |
| PSOC Dose Expansion Cohort: DNIB0600A+Carboplatin | EXPERIMENTAL | RP2D of DNIB0600A administered via IV infusion in combination with AUC=6 mg/mL\*min administered via IV infusion on Day 1 of each 21-day cycle in participants with PSOC until disease progression or death, whichever occurs first. |
| PSOC Dose Expansion Cohort: DNIB0600A+Carboplatin+Bevacizumab | EXPERIMENTAL | RP2D of DNIB0600A administered via IV infusion in combination with Carboplatin, AUC=6 mg/mL\*min and Bevacizumab 15 milligrams per kilogram (mg/kg) administered via IV infusion on Day 1 of each 21-day cycle in participants with PSOC until disease progression or death, whichever occurs first. |
| Dose Escalation Cohort (DNIB0600A) | EXPERIMENTAL | Participants will receive IV infusions of DNIB0600A at doses ranging from 0.2 milligrams/kilogram (mg/kg) to 2.8 mg/kg q3w until dose-limiting toxicity (DLT) is reached, or up to 28 cycles. |
| Expansion Cohort (DNIB0600A) | EXPERIMENTAL | Participants will receive 2.4 mg/kg, by IV infusion, of DNIB0600A q3w for up to 26 cycles. |
| Name | Type | Description |
|---|---|---|
| Bevacizumab | DRUG | Bevacizumab 15 milligrams per kilogram (mg/kg) administered via IV infusion on Day 1 of each 21-day cycle until disease progression or death, whichever occurs first. |
| Carboplatin | DRUG | Carboplatin fixed dose of AUC=6 mg/mL\*min administered by IV infusion on Day 1 of each 21-day dose escalation and expansion cycles. Carboplatin will be administered for a maximum of 6 cycles or until disease progression or unacceptable toxicity, whichever is first. |
| DNIB0600A | DRUG | DNIB0600A at an initial dose of 1.2 mg/kg will be administered via IV infusion further following a dose-escalation until DLT under consultation of the investigator on Day 1 of 21 day dose-escalation cycle. RP2D will be administered further in dose-expansion for until disease progression or death, whichever occurs first. |
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) status of 0 or 1. * Histologically documented epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that is platinum sensitive. * PSOC (i.e., epithelial ovarian cancer, primary peritoneal cancer, or fallopian t...
DNIB0600A is an investigational oncology drug being studied for the treatment of Non-Squamous Non-Small Cell Lung Cancer, Non-Small Cell Lung Cancer, and Ovarian Cancer. It is a small molecule developed by Roche Holding AG and is currently in Phase 1 clinical development.
DNIB0600A is being developed by Roche Holding AG, which trades under the ticker RHHBY. The drug is an investigational small molecule intended for oncology indications, including Non-Small Cell Lung Cancer and Ovarian Cancer.
DNIB0600A is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. Two Phase 1 trials have been completed, with a total enrollment of 87 participants across the studies.
DNIB0600A has been studied in two completed Phase 1 trials. NCT01363947 evaluated escalating doses in participants with Non-Small Cell Lung Cancer and Platinum Resistant Ovarian Cancer, enrolling 87 participants in the United States and Spain. NCT01995188 assessed safety and pharmacology in Platinum-Sensitive Ovarian Cancer or Non-Squamous Non-Small Cell Lung Cancer, enrolling 41 participants in the United States.
DNIB0600A is the primary name for this investigational drug. No alternative names have been reported for this asset. It is a small molecule being developed by Roche Holding AG for oncology indications.