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A pilot study targeting lower rectal and anal adenocarcinoma for preliminary efficacy and safety of OBP-301 in combination with chemoradiation therapy

A pilot study of OBP-301 in combination with neoadjuvant chemoradiation therapy targeting lower rectal and anal adenocarcinoma.

Fukino Koichi

Oncolys Biopharma Inc.

4-1-28 Toranomon, Minato-ku, Tokyo

tr@oncolys.com

Fukino Koichi

Oncolys Biopharma Inc.

4-1-28 Toranomon, Minato-ku, Tokyo

+81-3-5472-1578

tr@oncolys.com

Pending

Aug. 28, 2026

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. Patients whose tumor is located primarily either in the lower rectum (Rb) or the anal canal (P).
2. Histologically confirmed adenocarcinoma by endoscopic biopsy of lower rectal or anal canal.
3. Eligible for curative surgery and neoadjuvant chemoradiation therapy.
4. Patients who request capecitabine treatment as a part of neoadjuvant therapy.
5. Patients whose tumor size can be covered 3-dimensionally by a total of 1 mL of OBP-301 injection..
- Other protocol-defined Inclusion criteria may apply.

1. Patients with other active tumors that require treatment with higher priority than that for lower rectal or anal adenocarcinoma.
2. Patients with active infection at baseline that require systemic therapy.
3. Patients with prior rectal resection (excluding endoscopic resection) or treatment history, including those for other tumors, of radiotherapy to pelvis and fluoropyrimidine-based therapy.
4. Patients with uncontrollable concurrent disease of important organs that principle investigator considers inappropriate for study participation.
- Other protocol-defined Exclusion criteria may apply.

Lower rectal and anal adenocarcinoma

OBP-301 (1 x 10^12 VP/mL) is administered weekly (Day 1, Day 11, Day 18, Day 25, Day 32 and Day 39) for a total of 6 intratumoral administration by endoscopic or direct injection. 1 mL volume is given per injection.

Capecitabine is administered p.o., BID of fixed dose based on body surface area (1,800 - 3,000 mg/day) is administered for 5 days followed by 2 days of rest, for a maximum of 56 times.

Radiation targeted to primary tumor and pelvic region is given 1.8 Gy/fraction/day from day 4 of chemotherapy (the first injection of OBP-301 as a Day 1) for 25 days, a total of 45 Gy. After this, 1.8 Gy/fraction/day targeted primary tumor is given for 3 days, rising a total radiation to 50.4 Gy.

1. Pathological complete response (pCR) rate
2. Adverse events; events, occurrence rate, grading (according to CTCAE v5.0-JCOG), relation to study treatment

1. Clinical complete response (cCR) rate
2. Clinical local complete response (cL-CR) rate
3. Neoadjuvant and pathological TNM
4. cCR + near CR rate
5. cL-CR + local-near CR rate
6. Pathological tumor regression grade

No

None