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DNIB0600A · 1 trial · 1 indication
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) | 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 |
|---|---|---|
| DNIB0600A | DRUG | Several dose levels will be evaluated for DNIB0600A administered via IV infusion on Day 1 of each 21-day cycle until disease progression. |
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Histologic documentation of incurable, locally advanced or metastatic disease that has failed prior chemotherapy and for which no standard therapy exists, including the following: non-squamous NSCLC or no...
DNIB0600A is an investigational small molecule developed by Roche Holding AG for the treatment of non-small cell lung cancer and platinum resistant ovarian cancer. It has been studied in a single Phase 1 clinical trial that is now completed. It is not an approved therapy and remains in clinical development.
DNIB0600A was studied for use in non-small cell lung cancer and platinum resistant ovarian cancer. Both are oncology indications. The clinical work to date consists of one completed Phase 1 trial, so DNIB0600A is investigational and is not an approved treatment for either cancer type.
DNIB0600A is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche sponsored the clinical program evaluating the compound in non-small cell lung cancer and platinum resistant ovarian cancer. The asset is an investigational small molecule within Roche's oncology pipeline.
DNIB0600A is in Phase 1 development. One Phase 1 trial has been conducted and is completed, with no active trials ongoing. Because the program has only reached Phase 1, DNIB0600A is investigational and has not been approved by the FDA for any indication.
DNIB0600A has been evaluated in one clinical trial, NCT01363947, titled Safety and Pharmacokinetics of Escalating Doses of DNIB0600A in Participants With Non-Small Cell Lung Cancer (NSCLC) and Platinum Resistant Ovarian Cancer. The Phase 1 study enrolled 87 participants across the United States and Spain and is completed.
The DNIB0600A Phase 1 trial NCT01363947 was a controlled, non-randomized, open-label dose escalation study. It enrolled 87 participants aged 18 years and older of all sexes, with no healthy volunteers, and assessed safety and pharmacokinetics in non-small cell lung cancer and platinum resistant ovarian cancer. It is completed.