NCT06171178

A Study of ASP1012 in Adults With Solid Tumors

Terminated Phase 1 Last updated 4 November 2025

What this trial tests

Phase 1 trial testing ASP1012 in Solid Tumor in 15 participants. Terminated before completion.

Timeline

15 May 2024

Primary endpoint
10 September 2025

10 September 2025

Quick facts

Lead sponsor	Astellas Pharma Global Development, Inc.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	15 May 2024
Primary completion	10 September 2025
Estimated completion	10 September 2025
Sites	8 locations across United States

Drugs / interventions tested

• ASP1012 — full drug profile →
• Pembrolizumab (pembrolizumab) — full drug profile →

Conditions studied

• Solid Tumor — all drugs for Solid Tumor →

Sponsor

Astellas Pharma Global Development, Inc. — full company profile →

Who can join

18 and older, any sex, with Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

ASP1012 is a type of virus called an oncolytic virus which is used to treat some cancers.

ASP1012 was changed in a laboratory to infect and kill cancer cells, leaving healthy cells alone. It also makes the cancer cells visible to the immune system which will fight the cancer cells.

Before ASP1012 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. This will help find a suitable dose for future studies and check for potential medical problems from the treatment.

In this study, ASP1012 is being tested in humans for the first time. ASP1012 has already been tested in the laboratory and in animals. This is the standard way new potential treatments are developed.

People in this study will be adults whose tumor has either grown outside of the area where it started (locally advanced) or it has spread to other parts of the body (metastatic). They will receive ASP1012. Also, some people will receive ASP1012 with pembrolizumab, an approved medicine.

There are 2 main aims of this study. The first is to learn if people with certain solid tumors can tolerate different doses of ASP1012. The second is to find a suitable dose of ASP1012.

This study will be in 3 parts.

Part 1 is called Dose Escalation. People with locally advanced or metastatic tumors can take part. They will have been previously treated with all available standard cancer therapies. Different small groups of people will receive lower to higher doses of ASP1012.

For each dose, any medical problems will be recorded. This will help to find suitable doses of ASP1012 to use in Parts 2 and 3 of the study. The first group will receive the lowest dose of ASP1012. A medical expert panel will check the results from this group and decide if the next group can receive a higher dose of ASP1012. The panel will do this for each group until all groups have taken ASP1012 or until suitable doses have been selected for Parts 2 and 3.

Part 2 is called Dose Expansion. 3 groups will take part: people with previously-treated melanoma (a type of skin cancer) that have not responded to their treatment (refractory) or their cancer has come back (relapsed), people with newly-diagnosed or untreated melanoma, and people with previously-treated solid tumors. People with previously-treated melanoma will receive ASP1012 at the dose worked out from Part 1. People with previously-treated solid tumors will receive ASP1012 with pembrolizumab. The first few people will receive ASP1012 at a lower dose than the dose worked out from Part 1, to check the safety of the treatments being given together. If there are no safety issues: the next people in the solid tumor group will receive ASP1012 at the dose worked out from Part 1, with pembrolizumab; also people with untreated melanoma will receive ASP1012 at the dose worked out from Part

1, with pembrolizumab.

Part 3 is also a Dose Expansion for people with other specific cancers. These are stomach cancer, ovarian cancer, or colorectal cancer. If people with certain tumors respond well in Parts 1 and 2 of the study, other people with this same type of tumor can also take part in Part 3.

For all parts of the study, ASP1012 will be given through a vein. This is called an infusion.

Each treatment cycle is 21 days long. People will start with 3 treatment cycles. People in the study may receive extra treatment cycles, if they respond well to treatment. People with melanoma who are receiving ASP1012 with pembrolizumab will not be offered the extra treatment cycles. People can stop leave the study early if: they have medical problems from the treatment; their cancer gets worse; they start other cancer treatment; they ask to stop treatment; or they do not come back for treatment.

People will visit the clinic on certain days during their treatment. Some visits will be virtual or by phone. During all clinic visits, the study doctors will check for any medical problems from ASP1012. They will also check vital signs. Vital signs include temperature, pulse, breathing rate, the amount of oxygen in the blood, and blood pressure. At some visits, other checks will also include a medical examination, and an electrocardiogram (ECG) to check the heart rhythm, blood draws and urine samples for testing. A tumor sample, if available, will be taken during the first treatment cycle. People will have imaging scans and have blood draws for testing every 6 weeks during and after treatment. This will stop if they leave the study early.

People will visit the clinic within 7 days and 30 days after stopping treatment. At both visits, the study doctors will check for any medical problems from ASP1012. Other checks will include a medical examination, blood draws and urine samples for testing and checking vital signs. An ECG will also be done at the 7-day visit. After the 30-day visit, clinic staff will phone people in the study every 12 weeks to check the condition of their cancer for up to 1 year.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current trends in sensitizing immune checkpoint inhibitors for cancer treatment.
   Wei J, Li W, Zhang P, Guo F, et al · · 2024 · cited 82× · PMID 39725966 · DOI 10.1186/s12943-024-02179-5
2. Oncolytic immunovirotherapy: finding the tumor antigen needle in the antiviral haystack.
   Kendall BL, Vile RG. · · 2025 · cited 3× · PMID 40474818 · DOI 10.1080/1750743x.2025.2513853
3. Oncolytic viruses: advanced strategies in cancer therapy.
   Xiao D, Zhang H, Liu Y, Li Y, et al · · 2026 · cited 2× · PMID 41639062 · DOI 10.1038/s41392-025-02343-3
4. Advances in Oncolytic Viral Therapy in Melanoma: A Comprehensive Review.
   Garg A, Rao R, Tejawinata F, Shamita GAN, et al · · 2025 · cited 2× · PMID 40733704 · DOI 10.3390/vaccines13070727
5. Where Are We Now with Oncolytic Viruses in Melanoma and Nonmelanoma Skin Malignancies?
   Nassief G, Anaeme A, Moussa K, Chen D, et al · · 2024 · cited 2× · PMID 39065766 · DOI 10.3390/ph17070916
6. Phase 1 open-label study of ASP9801, an oncolytic virus, in patients with advanced or metastatic solid tumors.
   Villano JL, Luke JJ, Julian R, Fountzilas C, et al · · 2026 · PMID 41672594 · DOI 10.1136/jitc-2025-012377