Phase 2
Completed N=97
A Study of Emibetuzumab in Combination With Ramucirumab (LY3009806) in Participants With Advanced Cancer
Source: ClinicalTrials.gov NCT02082210 ↗Enrolled (actual)
97
Serious AEs
36.1%
Results posted
Dec 2020
Primary outcomePrimary: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) — 0; 0; 0; 0 Participants
Summary
The purpose of this study is to find a recommended schedule and dose range for Emibetuzumab when given with ramucirumab that may be safely given to participants with cancer. In Part A of this study, escalating doses of Emibetuzumab will be given in combination with a fixed dose of ramucirumab to evaluate the safety of the combination. After a recommended schedule and dose range of Emibetuzumab and ramucirumab has been established, Part B of the study will confirm safety and to see how well certain tumors respond to the combination of study drugs. The average amount of time on study is expected to be about 6 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Part B: Percentage of Participants Who Exhibit Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)] |
6.3; 6.7; 0; 6.7 | — |
| SECONDARY Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of Emibetuzumab |
210; 575 | — |
| SECONDARY Part B: Percentage of Participants Who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR) (Disease Control Rate [DCR]) |
50; 60; 46.7; 86.7 | — |
| SECONDARY Part B: Progression Free Survival (PFS) |
1.64; 5.42; 2.92; 6.57 | — |
| SECONDARY Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) From Time Zero to Tlast of Emibetuzumab |
29800; 86500 | — |
| SECONDARY Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Ramucirumab |
— | — |
| SECONDARY Number of Participants With Treatment Emergent Anti-Emibetuzumab Antibodies |
0; 0; 0; 3; 0; 0 | — |
| SECONDARY Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of Ramucirumab |
— | — |
| SECONDARY Number of Participants With Treatment Emergent Anti-Ramucirumab Antibodies |
1; 0; 0; 4; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Participants must have histological or cytological confirmed diagnosis of the following tumor types that is advanced and/or metastatic cancer and must be, in the judgment of the investigator, an appropriate participant for experimental therapy
- Part A: Any type of solid tumor ("all comer")
- Part B1: Gastric or Gastroesophageal Junction (GEJ) adenocarcinoma
- Part B2: Hepatocellular cancer (excluding fibrolamellar carcinoma)
- Part B3: Renal cell carcinoma (any histology)
- Part B4: Non-small cell lung cancer (squamous or non-squamous)
- Have at least 1 measurable lesion outside of the central nervous system (CNS) whose presence is assessable using standard techniques by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Availability of a tumor sample taken after progression on the most recent line of systemic tumor therapy or willing to undergo a tumor biopsy pre-study treatment.
- Have a performance status of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale in Part A and ≤ 1 on the ECOG scale in Part B.
- Have adequate organ function.
- Routine urinalysis showing ≤1+ protein or protein/creatinine ratio 470 milliseconds on screening electrocardiogram (ECG).
- Have received previous treatment with ramucirumab or Emibetuzumab, except for participants enrolled in cohort B1 (Gastric or GEJ adenocarcinoma) and B4 (non- small cell lung cancer) who may have received previous ramucirumab treatment.
- Known hypersensitivity to any of the treatment components of ramucirumab or Emibetuzumab.
- Have a second primary malignancy that, in the judgment of the investigator and sponsor, may affect the interpretation of results.
- Are pregnant or breastfeeding.
- For Part B4 (non-small cell lung cancer) only:
- The participant has radiologically documented evidence of major blood vessel invasion or encasement by cancer
- Participants with a history of gross hemoptysis within 2 months prior to study treatment
- The participant has radiographic evidence of intratumor cavitation, regardless of tumor histology
Data sourced from ClinicalTrials.gov (NCT02082210). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.