Phase 1 clinical trial of anti-CTLA4 human monoclonal antibody CP-675,206 in patients (pts) with advanced solid malignancies

Camacho, L. H.; Ribas, A.; Glaspy, John A.; Lopez‐Berestein, G.; Reuben, James M.; Parker, Charla A.; Seja, Elizabeth; Comin-Anduix, Begoñya; Bulanhagui, C. A.; Gómez-Navarro, Jesús

doi:10.1200/jco.2004.22.14_suppl.2505

Cited by 11 publications

(12 citation statements)

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“…Most patients who experienced clinical benefit had a tremelimumab plasma concentration that was ≥30 μg/mL, the predicted clinical target based on preclinical studies, even 4 weeks post-dose. Clearance was low (mean = 0.132 mL/h/kg), and the steady-state volume of distribution was small (mean = 81.2 mL/kg) 1,25. The terminal-phase half-life of tremelimumab was 22.1 days, consistent with natural IgG2 1,26.…”

Section: Tremelimumabmentioning

confidence: 82%

“…The objective response rate (RR) was 10% (2 complete remission (CR), 2 partial response (PR); all melanoma and all durable lasting 25 to 34 months) observed at the 3, 10, and 15 mg/kg dosing levels 1,25. Four patients had stable disease (lasting 4 to 16 months).…”

Section: Tremelimumabmentioning

confidence: 99%

“…This study treated 39 patients with a single intravenous infusion of tremelimumab (0.01 to 15 mg/kg) 1,25. The maximum concentration (C max ; range, 2 to 450 μg/mL) and area under the curve (AUC) increased in an approximately proportional manner with dose 1,25. Most patients who experienced clinical benefit had a tremelimumab plasma concentration that was ≥30 μg/mL, the predicted clinical target based on preclinical studies, even 4 weeks post-dose.…”

Section: Tremelimumabmentioning

confidence: 99%

“…A total of 39 patients (melanoma = 34, renal cell carcinoma = 4, colon carcinoma = 1) were treated, including 33 patients with measurable disease and 6 patients with either surgically resected or nonmeasurable disease 1,25. Five patients in the lowest dose cohorts (0.01 to 1 mg/kg) were re-enrolled at a higher dose level for a total of 44 administered doses.…”

Section: Tremelimumabmentioning

confidence: 99%

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CTLA-4 blockade: therapeutic potential in cancer treatments

Tarhini¹

2010

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Enhancing or prolonging T-cell activation by monoclonal antibodies (mAbs) blocking negative signaling receptors such as CTLA4 is one approach to overcoming tumor-induced immune tolerance. Ipilimumab and tremelimumab inhibit CTLA4, prolonging antitumor immune responses and leading to durable anti-tumor effects. Treatment with these mAbs has demonstrated clinically important and durable tumor responses and disease control rates in patients with unresectable advanced melanoma. Durable objective responses have been reported across a spectrum of doses and schedules, with relative safety in this patient population. Although the phase III tremelimumab melanoma study was closed for “futility”, the 1-year survival rate of >50% for tremelimumab and the median survival of 11.7 months (compared with 10.7 months for chemotherapy) are notable. Results of the phase III studies testing CTLA4-blockade with ipilimumab are eagerly anticipated. The further development of these agents includes testing in the neoadjuvant melanoma setting (ipilimumab) as well the adjuvant high-risk melanoma setting (ipilimumab). Future progress with CTLA-4 blockade therapy will also likely come from the use of combinations of agents that target several critical regulatory pathways of the immune system and modulate the immune response in the host in a synergistic and controlled fashion.

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Section: Tremelimumabmentioning

confidence: 82%

Section: Tremelimumabmentioning

confidence: 99%

Section: Tremelimumabmentioning

confidence: 99%

Section: Tremelimumabmentioning

confidence: 99%

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CTLA-4 blockade: therapeutic potential in cancer treatments

Tarhini¹

2010

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“…All autoimmune adverse events except vitiligo were manageable and reversible. [10] 2.3 Pharmacodynamics…”

Section: Solid Tumorsmentioning

confidence: 99%

Tremelimumab

2010

Drugs R D

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Tremelimumab (CP 675206;206; CP-675206; Ticilimumab) is a fully human IgG2 anitbody, which is directed against human cytotoxic T lymphocyte-associated antigen 4 (CTLA4). It is being developed by Pfizer for the treatment of various cancers. It is currently in worldwide phase III development for malignant melanoma, phase II development for colorectal cancer, gastrointestinal cancer, gynecological cancer, and non-small cell lung cancer in the US and other countries, and is also being investigated for prostate, breast, and pancreatic cancer in various countries. This review discusses the key development milestones and therapeutic trials of this drug.

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Current awareness: Pharmacoepidemiology and drug safety

2004

Pharmacoepidemiology and Drug

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In order to keep subscribers up‐to‐date with the latest developments in their field, John Wiley & Sons are providing a current awareness service in each issue of the journal. The bibliography contains newly published material in the field of pharmacoepidemiology and drug safety. Each bibliography is divided into 19 sections: 1 Books, Reviews & Symposia; 2 General; 3 Anti‐infective Agents; 4 Cardiovascular System Agents; 5 CNS Depressive Agents; 6 Non‐steroidal Anti‐inflammatory Agents; 7 CNS Agents; 8 Anti‐neoplastic Agents; 9 Haematological Agents; 10 Neuroregulator‐Blocking Agents; 11 Dermatological Agents; 12 Immunosuppressive Agents; 13 Autonomic Agents; 14 Respiratory System Agents; 15 Neuromuscular Agents; 16 Reproductive System Agents; 17 Gastrointestinal System Agents; 18 Anti‐inflammatory Agents ‐ Steroidal; 19 Teratogens/fetal exposure; 20 Others. Within each section, articles are listed in alphabetical order with respect to author. If, in the preceding period, no publications are located relevant to any one of these headings, that section will be omitted.

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Phase 1 clinical trial of anti-CTLA4 human monoclonal antibody CP-675,206 in patients (pts) with advanced solid malignancies

Cited by 11 publications

References 0 publications

CTLA-4 blockade: therapeutic potential in cancer treatments

CTLA-4 blockade: therapeutic potential in cancer treatments

Tremelimumab

Current awareness: Pharmacoepidemiology and drug safety

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