NL-OMON54211RecruitingNot Applicable
A Phase 1, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI5752 in Subjects with Advanced Solid Tumors - 0597/0102 (MedImmune D7980C00001)
MedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC0 sites10 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 10
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 64 (—)
Inclusion Criteria
- •General criteria applicable to the entire population enrolled in the study: 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 Body weight (WT) > 35 kg 6 Subjects who have received
- •prior anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy or any prior chemotherapy,
- •investigational, biologic, or hormonal therapy for cancer treatment may be
- •eligible to enter the study (see inclusion criterion #20 [RCC-C1] and #28
- •[RCC-C2] for requirements for RCC expansion cohorts and #25 for requirements
- •for NSCLC expansion cohorts) [NSCLC-C1 and NSCLC-C2]) following a washout
- •period of these treatments of at least 21 days before the first dose; 7 day
- •washout period is required for palliative radiotherapy (exception: 14-day
- •washout period for central nervous system [CNS] metastases) and washout period
- •of 5 half-lives is required for TKIs before the first dose; 7 Females of
- •childbearing potential who are sexually active with a nonsterilized male
- •partner must use at least one highly effective method of contraception (See
- •Table 27 in the protocol for recommended methods of contraception) from
- •screening and must agree to continue using such precautions for the specified
- •number of days after the final dose of investigational product: (a) MEDI5752:
- •90 days (b) Carboplatin: 90 days (c) Pemetrexed: 180 days (d) Pembrolizumab:
- •120 days (e) Paclitaxel: 6 months (ie, 180 days) (f) Nab-paclitaxel: 6 months
- •(ie, 180 days) See protocol for definition of Females of childbearing potential
- •definition. 8 Nonsterilized males who are sexually active with a female partner
- •of childbearing potential must use a male condom with spermicide where locally
- •available from Day 1 and for 90 days after the final dose of investigational
- •product. Males receiving pemetrexed, carboplatin, paclitaxel, or nab-paclitaxel
- •treatment must use contraception during study treatment and up to 6 months
- •thereafter. Male subjects should refrain from sperm donation throughout this
- •period. It is strongly recommended that the female partner of childbearing
- •potential to use at least one highly effective method of contraception (see
- •protocol). Not engaging in sexual activity is an acceptable practice; however,
- •occasional abstinence, the rhythm method, and the withdrawal method are not
- •acceptable methods of contraception. 9 Subjects must have at least one
- •measurable lesion according to RECIST v1.1. A previously irradiated lesion can
- •be considered a target lesion if the lesion is progressing and well defined,
- •accurately measured at baseline as being >= 10 mm in the longest diameter
- •(except lymph nodes, which must have a short axis >= 15 mm) with CT or magnetic
- •resonance imaging (MRI), and that is suitable for accurate repeated
- •measurements as per RECIST v1.1 guidelines. Subjects must consent to providing
- •the prior CT scan or MRI before enrolling in the study. Radiographic disease
- •assessment at baseline can be performed up to 28 days prior to the first dose
- •of investigational product. For subjects who undergo biopsies on study, the
- •biopsied lesion must be distinct from any lesion used in the RECIST evaluation.
- •10 Adequate organ and marrow funct
Exclusion Criteria
- •1 Involvement in the planning and/or conduct of the study (applies to both
- •MedImmune staff and/or staff at the study site) 2 Concurrent enrollment in
- •another clinical study, unless it is an observational (noninterventional)
- •clinical study or the follow-up period of an interventional study 3 Any prior
- •Grade >= 3 imAE while receiving immunotherapy or any unresolved imAE > Grade 1 4
- •For subjects who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4: (a)
- •Subjects must not have received anti-PD-1, anti-PD-L1, anti-CTLA-4 or any other
- •immunotherapy or IO agent within 21 days of commencing treatment with
- •investigational product. (b) Subject must not have experienced a toxicity that
- •led to permanent discontinuation of prior immunotherapy. (c) All AEs while
- •receiving prior immunotherapy must have completely resolved or resolved to
- •Grade 1 prior to screening for this study. NOTE: Subjects with an endocrine AE
- •of <= Grade 2 are permitted to enroll if they are stably maintained on
- •appropriate endocrine replacement therapy and are asymptomatic. (d) Subject
- •must not have experienced a >= Grade 3 imAE or an immune-related neurologic or
- •ocular AE of any grade while receiving prior immunotherapy. NOTE: Subjects with
- •endocrine AE of <= Grade 2 are permitted to enroll if they are stable on
- •appropriate replacement therapy and are asymptomatic. (e) Subject must not have
- •required the use of additional immunosuppression other than corticosteroids for
- •the management of an AE, must not have experienced recurrence of an AE if
- •rechallenged, and must not currently require maintenance doses of > 12 mg
- •prednisone or equivalent per day. 5 Any concurrent chemotherapy, radiotherapy,
- •investigational, biologic, or hormonal therapy for cancer treatment (see
- •Inclusion Criterion 6 for washout periods [Section 4.1.2]). Concurrent use of
- •hormonal therapy for noncancer-related conditions (eg, insulin for diabetes and
- •hormone replacement therapy) is acceptable. NOTE: Local treatment of isolated
- •lesions for palliative intent is acceptable (eg, metastasis treated by local
- •surgery or radiotherapy) 6 Current or prior use of immunosuppressive medication
- •within 14 days before the first dose of investigational product is excluded.
- •The following are exceptions to this criterion: (a) Intranasal, inhaled,
- •topical steroids, or local steroid injections (eg, intraarticular injection)
- •(b) Steroids as premedication for hypersensitivity reactions (eg, CT scan
- •premedication) or a single dose for palliative purpose (eg, pain control) 7
- •Receipt of live attenuated vaccine within 30 days prior to the first dose of
- •investigational product. Note: Subjects, if enrolled, should not receive live
- •vaccine while receiving investigational product and up to 30 days after the
- •last dose of investigational product. 8 Active or prior documented autoimmune
- •or inflammatory disorders including inflammatory bowel disease (eg, colitis or
- •Crohn's disease), diverticulitis (with the exception of diverticulosis),
- •systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome
- •(granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis,
- •hypophysitis, uveitis, pneumonitis (past medical history of ILD, drug induced
- •ILD. Radiation pneumotitis requiring steroid treatment or any evidence of
- •clinically active ILD),etc). The fol
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