NCT01644968

Phase 1 Trial of a Monoclonal Antibody to OX40 in Patients With Advanced Cancer.

Completed Phase 1 Last updated 16 May 2022

What this trial tests

Phase 1 trial testing Cohort 1 anti-OX40 in Advanced Cancer in 30 participants. Completed in 1 April 2017.

Timeline

1 November 2003

Primary endpoint
1 May 2009

1 April 2017

Quick facts

Lead sponsor	Providence Health & Services
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 November 2003
Primary completion	1 May 2009
Estimated completion	1 April 2017
Sites	1 location across United States

Drugs / interventions tested

• Cohort 1 anti-OX40
• Cohort 2 anti-OX40
• Cohort 3 anti-OX40
• Tetanus Day 29 — full drug profile →
• Tetanus Day 1 — full drug profile →
• KLH Day 1 — full drug profile →
• KLH Day 29 — full drug profile →

Conditions studied

• Advanced Cancer — all drugs for Advanced Cancer →

Sponsor

Providence Health & Services — full company profile →

Who can join

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

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Dose limiting toxicity
  Time frame: 28 Days
  A dose limiting toxicity is defined as any grade \>=3 hematologic (except lymphopenia) or non-hematologic toxicity (except hypothyroidism or vitiligo) that, in the opinion of the investigator is considered at lease possibly related to the study treatment. If DLT is observed in greater than two patient in any cohort, then the previous cohort will be the maximal tolerated dose.

Sponsor's own description

This study is designed to determine the safety and highest tolerated dose of anti-OX40 in patients with advanced cancer.

Publications & conference data

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

1. Immunotherapy in colorectal cancer: rationale, challenges and potential.
   Ganesh K, Stadler ZK, Cercek A, Mendelsohn RB, et al · · 2019 · cited 1407× · PMID 30886395 · DOI 10.1038/s41575-019-0126-x
2. Regulatory T cells in tumor microenvironment: new mechanisms, potential therapeutic strategies and future prospects.
   Li C, Jiang P, Wei S, Xu X, et al · · 2020 · cited 679× · PMID 32680511 · DOI 10.1186/s12943-020-01234-1
3. Next generation of immune checkpoint therapy in cancer: new developments and challenges.
   Marin-Acevedo JA, Dholaria B, Soyano AE, Knutson KL, et al · · 2018 · cited 582× · PMID 29544515 · DOI 10.1186/s13045-018-0582-8
4. OX40 is a potent immune-stimulating target in late-stage cancer patients.
   Curti BD, Kovacsovics-Bankowski M, Morris N, Walker E, et al · · 2013 · cited 369× · PMID 24177180 · DOI 10.1158/0008-5472.can-12-4174
5. Eradication of spontaneous malignancy by local immunotherapy.
   Sagiv-Barfi I, Czerwinski DK, Levy S, Alam IS, et al · · 2018 · cited 282× · PMID 29386357 · DOI 10.1126/scitranslmed.aan4488
6. Timing of PD-1 Blockade Is Critical to Effective Combination Immunotherapy with Anti-OX40.
   Messenheimer DJ, Jensen SM, Afentoulis ME, Wegmann KW, et al · · 2017 · cited 249× · PMID 28855348 · DOI 10.1158/1078-0432.ccr-16-2677
7. OX40 Agonists and Combination Immunotherapy: Putting the Pedal to the Metal.
   Linch SN, McNamara MJ, Redmond WL. · · 2015 · cited 174× · PMID 25763356 · DOI 10.3389/fonc.2015.00034
8. PD-1 blockade and OX40 triggering synergistically protects against tumor growth in a murine model of ovarian cancer.
   Guo Z, Wang X, Cheng D, Xia Z, et al · · 2014 · cited 153× · PMID 24586709 · DOI 10.1371/journal.pone.0089350