A Phase I Study of RG3638 as a Single Agent in Patients with Solid Tumors, and RG3638 in Combination with Erlotinib in Patients with Met diagnostic-positive Non-Small Cell Lung Cancer.

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221523

Enrollment

Registered

2011-07-28

Start date

2011-07-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumors(Stage 1), Met diagnostic-positive Non-Small Cell Lung Cancer (Stage 2)

Interventions

investigational material(s) Generic name etc : RG3638(PRO143966) INN of investigational material : onartuzumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Inve

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Histologically or cytologically confirmed solid tumor - Advanced or recurrent cancer that is refractory to the standard of care or for which there is no standard of care - PS of 0 or 1 - Histologically or cytologically confirmed non-small cell lung cancer - Received at least 1 prior regimen involving systemic chemotherapy with a platinum-containing agent - Met diagnostic-positive - PS of 0 or 1

Exclusion criteria

Exclusion criteria: - Primary central nervous system malignancy or symptomatic or treatment-requiring central nervous system metastases - Prior treatment with a drug that acts predominantly by inhibiting Met - Concurrent or prior radiographically-evident interstitial lung disease (including interstitial pneumonia, pneumonitis, radiation pneumonitis, organizing pneumonia, pulmonary fibrosis, acute respiratory distress syndrome, pulmonary infiltration and alveolitis)

Design outcomes

Primary

Measure	Time frame
DLT, adverse event profile, pharmacokinetics, MTD, recommemded clinical dose CTCAE ver. 4.03	—

Secondary

Measure	Time frame
anti-tumor activity, anti-therapeutic antibody RECIST ver. 1.1	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026