Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MEDI5752 · 3 trials · 3 indications
The primary endpoint is as assessed by the number of subjects experiencing adverse events (AEs) graded per NCI CTCAE v5.0.
The primary endpoint is as assessed by the number of subjects with serious adverse events (SAEs) graded per NCI CTCAE v5.0.
The primary endpoint is as assessed by the number of subjects experiencing dose limiting toxicities (DLTs) as defined by the protocol.
The primary endpoint is as assessed as the number of subjects experiencing changes in laboratory parameters from baseline.
The primary endpoint is as assessed by the number of subjects experiencing clinically significant changes in vital signs from baseline.
The primary endpoint is as assessed by the the number of subjects experiencing clinically significant changes in ECG parameters from baseline.
The primary safety endpoint is as assessed by the number of subjects with adverse events and serious adverse events (SAEs) graded per NCI CTCAE v5.0.
Determine the MTD and recommended Phase 2 dose (RP2D) of the combination of MEDI5752 and Lenvatinib. A dose limiting toxicity (DLT) is defined as MEDI5752 treatment-related AE of any Grade 3 or higher toxicity (as defined in the protocol) CTCAE v5.0.
The primary safety endpoint is as assessed by the number of subjects with serious adverse events (SAEs) graded per NCI CTCAE v5.0.
The primary safety endpoint is as assessed by the number of subjects experiencing changes in laboratory evaluations from baseline.
The primary safety endpoint is assessed by the change in vital signs from baseline.
The primary safety endpoint is as assessed by the change in ECG parameters from baseline.
The primary efficacy endpoint is assessed by the antitumor activity of MEDI5752 combined with Lenvatinib.
The primary endpoint is as assessed by the number of subjects experiencing adverse events (AEs) graded per NCI CTCAE v4.03
The primary endpoint of antitumor activity include Objective Response and will be based on all post baseline disease assessments that occur prior to initiation of subsequent anticancer therapy.
The primary endpoint is as assessed by the number of subjects experiencing dose limiting toxicities (DLTs) as defined by the protocol.
The primary endpoint is as assessed as the number of subjects experiencing changes in laboratory parameters from baseline.
The primary endpoint is as assessed by the number of subjects experiencing clinically significant changes in vital signs from baseline.
The primary endpoint is as assessed by the the number of subjects experiencing clinically significant changes in ECG parameters from baseline.
The primary endpoint is as assessed by the number of subjects with serious adverse events (SAEs) graded per NCI CTCAE v4.03.
| Arm | Type | Description |
|---|---|---|
| MEDI5752 monotherapy | EXPERIMENTAL | - |
| Dose Exploration | EXPERIMENTAL | The Dose exploration Phase is made up of Part A, B and Part C. Part A will evaluate the safety and tolerability of MEDI5752 in combination with Axitinib (2 patients), and Part B and C will evaluate the safety and tolerability of MEDI5752 in combination with Lenvatinib (\~72 patients) |
| Dose Expansion | EXPERIMENTAL | Evaluate safety and anti-tumor activity of MEDI5752 in combination with Lenvatinib (\~105 patients ) |
| Arm A: MEDI5752 | EXPERIMENTAL | MEDI5752 |
| Arm B: MEDI5752 and chemotherapy | EXPERIMENTAL | MEDI5752, pemetrexed, carboplatin and paclitaxel. |
| Arm C: Pembrolizumab and chemotherapy | ACTIVE_COMPARATOR | pembrolizumab, pemetrexed, and carboplatin |
| Name | Type | Description |
|---|---|---|
| MEDI5752 | BIOLOGICAL | Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation. |
| Axitinib | DRUG | INLYTA |
| Lenvatinib | DRUG | LENVIMA |
| Pemetrexed | DRUG | Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation |
| Carboplatin | DRUG | Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation |
| Pembrolizumab | BIOLOGICAL | Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation |
| Paclitaxel or Nab-Paclitaxel | DRUG | Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation |
Inclusion Criteria 1. Age ≥ 18 years at the time of screening 2. World Health Organization/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment 3. Life expectancy ≥ 12 weeks 4. Histologically or cytologically-confirmed advanced solid tumors 5. Subjects who have recei...
MEDI5752 is an investigational monoclonal antibody being studied for the treatment of selected advanced solid tumors, advanced solid tumors, and advanced renal cell carcinoma. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
MEDI5752 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The drug is in Phase 1 clinical trials for oncology indications.
MEDI5752 is in Phase 1 clinical development. It is an investigational drug and has not received regulatory approval. Clinical trials are ongoing to evaluate its safety and efficacy in patients with advanced solid tumors and advanced renal cell carcinoma.
MEDI5752 is being studied in three Phase 1 clinical trials. NCT03530397 evaluates the drug in subjects with selected advanced solid tumors. NCT04522323 studies MEDI5752 in combination with axitinib in advanced renal cell carcinoma. NCT05685472 was conducted in Japanese patients with advanced solid tumors.
No alternative names for MEDI5752 have been disclosed. The drug is identified solely by its code name MEDI5752 in clinical trial registries and scientific literature.